CUB PEDIATRIC CRIB- FIXED BASE Adverse Event — Malfunction (MDR 0001831750-2020-00469)
CUB PEDIATRIC CRIB- FIXED BASE Adverse Event — Malfunction (MDR 0001831750-2020-00469) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: CUB PEDIATRIC CRIB- FIXED BASE; Generic name: BED, PEDIATRIC OPEN HOSPITAL; Manufacturer: STRYKER MEDICAL-KALAMAZOO.
| Device | CUB PEDIATRIC CRIB- FIXED BASE |
|---|---|
| Generic name | BED, PEDIATRIC OPEN HOSPITAL |
| Manufacturer | STRYKER MEDICAL-KALAMAZOO |
| Report number | 0001831750-2020-00469 |
| 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. THE DEVICES WERE EVALUATED IN THE FIELD AND THE ISSUE WAS CONFIRMED; 2 DEVICES HAD BROKEN/DAMAGED COMPONENTS AND 1 DEVICE HAD ALIGNMENT ISSUES. 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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