S3 EX - 3005 Adverse Event — Malfunction (MDR 0001831750-2020-00408)
S3 EX - 3005 Adverse Event — Malfunction (MDR 0001831750-2020-00408) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: S3 EX - 3005; Generic name: BED, AC-POWERED ADJUSTABLE HOSPITAL; Manufacturer: STRYKER MEDICAL-KALAMAZOO.
| Device | S3 EX - 3005 |
|---|---|
| Generic name | BED, AC-POWERED ADJUSTABLE HOSPITAL |
| Manufacturer | STRYKER MEDICAL-KALAMAZOO |
| Report number | 0001831750-2020-00408 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| 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. 2 DEVICES WERE EVALUATED IN THE FIELD AND THE ISSUE WAS CONFIRMED; THE DEVICES HAD WORN COMPONENTS. 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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