MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-19 for ENVELLA AIR FLUIDIZED THERAPY BED P0819A manufactured by Hill-rom Inc..
[128249786]
Hill-rom envella bed ordered for pressure relief for morbidly obese, immobile, ventilated patient. Electrical issue (per the communications from both baxter and hill rom is r/t static electricity) caused baxter iv pumps to shut down and restart with error message 341. This occurred with multiple pumps and could have led to interruption of critical med strips.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5081502 |
| MDR Report Key | 8090627 |
| Date Received | 2018-11-19 |
| Date of Report | 2018-11-07 |
| Date of Event | 2018-10-31 |
| Date Added to Maude | 2018-11-20 |
| 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 | ENVELLA AIR FLUIDIZED THERAPY BED |
| Generic Name | BED, AIR FLUIDIZED |
| Product Code | INX |
| Date Received | 2018-11-19 |
| Model Number | P0819A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HILL-ROM INC. |
| Manufacturer Address | 1069 STATE ROUTE 46 EAST BATESVILLE IN 47006 US 47006 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-11-19 |