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- Linn Ekos Serial Numbers Doreen
- Serial Numbers Microsoft
| 510(k) | | DeNovo | | Registration & Listing | | Adverse Events | | Recalls | | PMA | | HDE | | Classification | | Standards |
| CFR Title 21 | | Radiation-Emitting Products | | X-Ray Assembler | | Medsun Reports | | CLIA | | TPLC |
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Linn Cartridge Part-Exchange Values Kandid Krystal Akiva 1,035 238 Arkiv B 774 238 Arkiv 655 238 Krystal 387 238 Klyde / Troika 262 161 Karma 161 90 Asaka 131 79 B efore any trade -in is agreed, the serial number of the cartridge being tr aded-in must be checked with Linn - please contac t orders@linn. Co.uk Turntable Components. Linn’s 1988 model, the Ekos, was the first tonearm to be built in-house. More affordable turntables, called Axis and Basik were launched in 1985 and 1989 respectively. In 1990, Linn introduced an external power supply for the LP12 called the Lingo, providing more precise motor-speed control, and eliminating distorting effects of housing a.


| EKOS CORP. EKOSONIC ENDOVASCULAR SYSTEM | Back to Search Results |
| | Model Number 106CM / 12 CM | | Device Problems Restricted Flow rate (1248); Improper Flow or Infusion (2954) | | Patient Problem No Consequences Or Impact To Patient (2199) | | Event Date 01/27/2015 | | Event Type Malfunction | | Event Description | Event desc: the ekos catheter would not flush properly. The procedure was able to be completed successfully with another ekos catheter. There were no complications. What was the original intended procedure: pulmonary angiogram with hemodynamic pressures. Placement of bilateral 12 cm working length ekos sonothrombolysis catheters. Device usage problem: device failed (e. G. Broke, couldn't get it to work or stopped working). Event reported to ekos: the catheter would not flush properly. The catheter was never placed in a patient. | | Manufacturer Narrative | Although the user facility report indicated the device was a 12 cm ekosonic device, serial number (b)(4), the device returned to ekos for investigation was a 6 cm ekosonic device, serial number (b)(4). Additionally, although the customer reported the device was never used in a patient, inspection of the returned device confirmed the drug infusion lumens were filled with dried blood. This condition is consistent with having been placed in a patient and the blood filled infusion lumens also most likely caused the reported event. No patient injury was reported and the patient was reported to have a 'good' outcome. | | Search Alerts/Recalls |
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| New Search Submit an Adverse Event Report |
| Manufacturer (Section D) | | EKOS CORP. | | 11911 n creek parkway south | | bothell WA 98011 |
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| Manufacturer Contact | | 11911 n creek parkway south | | bothell, WA 98011 | | 4254153132 |
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| MDR Report Key | 4861539 |
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| MDR Text Key | 5851076 |
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| Report Number | 3001627457-2015-00004 |
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| Device Sequence Number | 1 |
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| Product Code | KRA |
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| Combination Product (Y/N) | N |
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| Reporter Country Code | US |
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| PMA/PMN Number | K140151 |
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| Number of Events Reported | 1 |
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| Summary Report (Y/N) | N |
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| Report Source | Manufacturer |
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| Source Type | User facility |
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| Reporter Occupation | RISK MANAGER |
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| Type of Report | Initial |
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| Report Date | 04/23/2015 |
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| 1 Device Was Involved in the Event |
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| 0 PatientS WERE Involved in the Event: |
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| Date FDA Received | 06/18/2015 |
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| Is This An Adverse Event Report? | No |
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| Is This A Product Problem Report? | Yes |
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| Device Operator | HEALTH PROFESSIONAL |
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| Device EXPIRATION Date | 08/01/2017 |
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| Device MODEL Number | 106CM / 12 CM |
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| Device Catalogue Number | 500-55112 |
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| Device LOT Number | 140827045-001 |
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| Was Device Available For Evaluation? | Yes |
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| Date Returned to Manufacturer | 02/17/2015 |
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| Is The Reporter A Health Professional? | Yes |
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| Was the Report Sent to FDA? | Yes |
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| Date Report Sent to FDA | 04/01/2015 |
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| Distributor Facility Aware Date | 01/27/2015 |
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| Device Age | 5 mo |
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| Event Location | Hospital |
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| Date Manufacturer Received | 05/15/2015 |
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| Was Device Evaluated By Manufacturer? | Yes |
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| Date Device Manufactured | 08/27/2014 |
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| Is The Device Single Use? | Yes |
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| Is this a Reprocessed and Reused Single-Use Device? | No |
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| Type of Device Usage | Initial |
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Linn Ekos Serial Numbers Doreen
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