MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-30 for HILL-ROM ENVELLA BED P0819A manufactured by Hill-rom, Inc..
[146890930]
The pt had muscle flap surgery on (b)(6) 2019, and the first wound dressing change the complete pt turning was on (b)(6) 2019. When the pt was turned to his side, a pressure injury was identified at the lower back. When wound nurse evaluated the pt, she placed her hand underneath the pt's back and noted that the air bladder for the bed was deflated and the pt's lower back made contact with the bed frame. At that time, hill-rom tech was on the unit and agreed with the wound care nurse and stated that the bed should alarm when there is a deflated bladder. The pt was placed on the unit and agreed with the wound care nurse and stated that the bed should alarm when there is a deflated bladder. The pt was placed on a waffle overlay while the bed was exchanged, which was completed on the same day. Hill-rom support ref number is (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5087041 |
| MDR Report Key | 8658570 |
| Date Received | 2019-05-30 |
| Date of Report | 2019-05-29 |
| Date of Event | 2019-05-21 |
| Date Added to Maude | 2019-05-31 |
| 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 |
| 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 | HILL-ROM ENVELLA BED |
| Generic Name | BED, AIR FLUIDIZED |
| Product Code | INX |
| Date Received | 2019-05-30 |
| Returned To Mfg | 2019-05-21 |
| Model Number | P0819A |
| Lot Number | (21)T117EN1580 # FOUND AFTER U |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HILL-ROM, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-05-30 |