ULTRA COMFRT, SE 4X30 DOMESTIC Adverse Event — Malfunction (MDR 0001831750-2020-00571)
ULTRA COMFRT, SE 4X30 DOMESTIC Adverse Event — Malfunction (MDR 0001831750-2020-00571) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ULTRA COMFRT, SE 4X30 DOMESTIC; Generic name: MATTRESS, FLOTATION THERAPY, NON-POWERED; Manufacturer: STRYKER MEDICAL-KALAMAZOO.
| Device | ULTRA COMFRT, SE 4X30 DOMESTIC |
|---|---|
| Generic name | MATTRESS, FLOTATION THERAPY, NON-POWERED |
| Manufacturer | STRYKER MEDICAL-KALAMAZOO |
| Report number | 0001831750-2020-00571 |
| 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 NOT EVALUATED, AS THE ISSUE WAS IDENTIFIED AND RESOLVED DURING A TROUBLESHOOTING CALL BETWEEN THE CUSTOMER AND STRYKER TECHNICAL SUPPORT. THERE WAS NO REMEDIAL ACTION TAKEN. THIS DEVICE IS NOT LABELED FOR SINGLE USE. |
| Source | openFDA MAUDE (device adverse events) |
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