MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-27 for ABTHERA? manufactured by Kci Usa, Inc..
[185223707]
During shift change turn/skin assessment, it was discovered that the pt's abdomen had been grossly distended and taut. A quick assessment showed that the abthera wound vac had turned off on its own. The vac was turned back on and immediately powered down again. The power cord was then switched to another outlet and when the vac was turned on again it stayed on. Approx 200 ml was pulled from abdomen after vac regained power.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9888476 |
| MDR Report Key | 9888476 |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-02-29 |
| Report Date | 2020-03-13 |
| Date Reported to FDA | 2020-03-13 |
| Date Reported to Mfgr | 2020-03-27 |
| Date Added to Maude | 2020-03-27 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 3 |
| Brand Name | ABTHERA? |
| Generic Name | NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP |
| Product Code | OMP |
| Date Received | 2020-03-27 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KCI USA, INC. |
| Manufacturer Address | 6203 FARINON DR. SAN ANTONIO TX 78249 US 78249 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-27 |