6083 AMBULANCE COT Adverse Event — Malfunction (MDR 0001831750-2020-00478)
6083 AMBULANCE COT Adverse Event — Malfunction (MDR 0001831750-2020-00478) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: 6083 AMBULANCE COT; Generic name: STRETCHER, WHEELED; Manufacturer: STRYKER MEDICAL-KALAMAZOO.
| Device | 6083 AMBULANCE COT |
|---|---|
| Generic name | STRETCHER, WHEELED |
| Manufacturer | STRYKER MEDICAL-KALAMAZOO |
| Report number | 0001831750-2020-00478 |
| 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. 1 DEVICE WAS EVALUATED IN THE FIELD BUT THE ISSUE WAS NOT CONFIRMED; NO DEFECT OR MALFUNCTION WAS FOUND. 1 DEVICE WAS EVALUATED IN THE FIELD AND THE ISSUE WAS CONFIRMED; THE DEVICE HAD A BENT COMPONENT. THE DEVICES WERE 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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