MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-05 for MAQUET ACROBAT SUV OM 9000S manufactured by Maquet.
[101778497]
Dr attempted to release the clamp on the device, the clamp hardware failed and became detached from either end of the two pieces of the clamp. No apparent injuries to the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075708 |
| MDR Report Key | 7317043 |
| Date Received | 2018-03-05 |
| Date of Report | 2018-03-01 |
| Date of Event | 2018-02-16 |
| Date Added to Maude | 2018-03-06 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | RISK MANAGER |
| 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 | 0 |
| Brand Name | MAQUET ACROBAT SUV |
| Generic Name | ACROBAT SUV VACUUM OFF PUMP SYSTEM |
| Product Code | NQG |
| Date Received | 2018-03-05 |
| Model Number | OM 9000S |
| Lot Number | 25134992 |
| Device Expiration Date | 2019-10-23 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET |
| Manufacturer Address | 45 BARBOUR POND DR. WAYNE NJ 07470 US 07470 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-03-05 |