MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-14 for ENVELLA manufactured by Hill-rom, Inc..
[144950465]
Pt on envella specialty bed, upon turning pt, noticed particles leaking out of mattress. All bed controls are working and pt is no distress. Called hillrom bed company multiple times in attempt to get a response as to when new bed can be delivered. Nursing supervisor made aware. Pt placed in our hospital bed while awaiting replacement specialty bed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8607245 |
| MDR Report Key | 8607245 |
| Date Received | 2019-05-14 |
| Date of Report | 2019-05-13 |
| Date of Event | 2019-04-05 |
| Report Date | 2019-05-13 |
| Date Reported to FDA | 2019-05-13 |
| Date Reported to Mfgr | 2019-05-14 |
| Date Added to Maude | 2019-05-14 |
| 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 | 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 | ENVELLA |
| Generic Name | BED, AIR FLUIDIZED |
| Product Code | INX |
| Date Received | 2019-05-14 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2019-05-14 |