ADVANTAGE SERIES 29 OBS10/04 Adverse Event — Malfunction (MDR 0001831750-2020-00515)
ADVANTAGE SERIES 29 OBS10/04 Adverse Event — Malfunction (MDR 0001831750-2020-00515) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ADVANTAGE SERIES 29 OBS10/04; Generic name: STRETCHER, WHEELED; Manufacturer: STRYKER MEDICAL-KALAMAZOO.
| Device | ADVANTAGE SERIES 29 OBS10/04 |
|---|---|
| Generic name | STRETCHER, WHEELED |
| Manufacturer | STRYKER MEDICAL-KALAMAZOO |
| Report number | 0001831750-2020-00515 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE |
| Narrative | THIS MDR IS PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. THE DEVICE WAS EVALUATED IN THE FIELD AND THE ISSUE WAS CONFIRMED; THERE WAS A WORN COMPONENT AND AN ALIGNMENT ISSUE. THE DEVICE WAS REPAIRED AND RETURNED. THERE WAS NO REMEDIAL ACTION TAKEN. THIS DEVICE IS NOT LABELED FOR SINGLE USE. |
| Source | openFDA MAUDE (device adverse events) |
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