MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-27 for CUB PEDIATRIC CRIB- HYD BASE FL19H manufactured by Stryker Medical-kalamazoo.
[177049480]
This mdr is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program. 24 devices were evaluated in the field and the issue was confirmed; 12 devices had broken/damaged components, four devices had alignment issues, three devices had worn components, two devices had detached components, one device had loose components, and two devices had bent components. The devices were repaired and returned. One device was not made available for testing by the customer; no cause was established. There was no remedial action taken. This device is not labeled for single use.
Patient Sequence No: 1, Text Type: N, H10
[177049481]
This report summarizes
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001831750-2020-00161 |
| MDR Report Key | 9633923 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-27 |
| Date of Report | 2020-01-27 |
| Date of Event | 2020-01-01 |
| Date Mfgr Received | 2020-01-01 |
| Date Added to Maude | 2020-01-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. KRISTEN CANTER |
| Manufacturer Street | 3800 EAST CENTRE AVENUE |
| Manufacturer City | PORTAGE MI 49002 |
| Manufacturer Country | US |
| Manufacturer Postal | 49002 |
| Manufacturer Phone | 2693292100 |
| Manufacturer G1 | STRYKER MEDICAL-KALAMAZOO |
| Manufacturer Street | 3800 EAST CENTRE AVENUE |
| Manufacturer City | PORTAGE MI 49002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CUB PEDIATRIC CRIB- HYD BASE |
| Generic Name | BED, PEDIATRIC OPEN HOSPITAL |
| Product Code | FMS |
| Date Received | 2020-01-27 |
| Model Number | FL19H |
| Catalog Number | FL19H |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER MEDICAL-KALAMAZOO |
| Manufacturer Address | 3800 EAST CENTRE AVENUE PORTAGE MI 49002 US 49002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-27 |