MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-03 for MODELS 5524, 5618, 5624 WARMING CABINET manufactured by Maquet Cardiovascular.
[181777081]
Staff have been cut by sharp edges on the shelves of warmers that have holes punched out for circulation. During regular stocking or removing of items they can cut staff. Staff was cut on a model 5624. ~3 weeks later, staff was cut on a different 5624 unit. Hospital has large inventory of warmers. 4 were checked in icn where incidents happened and all were found to have sharp edges around the holes on the underside of all three shelves in each warmer. Manufacturer response for warmer, (brand not provided) (per site reporter). Getinge plans to come to the hospital next week to look at the shelves.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9779376 |
| MDR Report Key | 9779376 |
| Date Received | 2020-03-03 |
| Date of Report | 2020-02-20 |
| Date of Event | 2020-01-04 |
| Report Date | 2020-02-21 |
| Date Reported to FDA | 2020-02-21 |
| Date Reported to Mfgr | 2020-03-03 |
| Date Added to Maude | 2020-03-03 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MODELS 5524, 5618, 5624 WARMING CABINET |
| Generic Name | WARMER, IRRIGATION SOLUTION |
| Product Code | LHC |
| Date Received | 2020-03-03 |
| Model Number | 5624 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 5 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET CARDIOVASCULAR |
| Manufacturer Address | 45 BARBOUR POND DR WAYNE NJ 07470 US 07470 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-03 |