SM204 M-SERIES W/BIG WHEEL Adverse Event — Malfunction (MDR 0001831750-2020-00553)
SM204 M-SERIES W/BIG WHEEL Adverse Event — Malfunction (MDR 0001831750-2020-00553) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: SM204 M-SERIES W/BIG WHEEL; Generic name: STRETCHER, WHEELED; Manufacturer: STRYKER MEDICAL-KALAMAZOO.
| Device | SM204 M-SERIES W/BIG WHEEL |
|---|---|
| Generic name | STRETCHER, WHEELED |
| Manufacturer | STRYKER MEDICAL-KALAMAZOO |
| Report number | 0001831750-2020-00553 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE |
| Narrative | THIS MDR IS A CONSOLIDATION OF RECORDS SUMMARIZED AS PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. 2 DEVICES WERE NOT EVALUATED, AS THE ISSUE WAS IDENTIFIED AND RESOLVED DURING A TROUBLESHOOTING CALL BETWEEN THE CUSTOMER AND STRYKER TECHNICAL SUPPORT. 77 DEVICES WERE EVALUATED IN THE FIELD AND THE ISSUE WAS CONFIRMED; 22 DEVICES HAD BROKEN/DAMAGED COMPONENTS, 5 DEVICES HAD MISSI |
| Source | openFDA MAUDE (device adverse events) |
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