MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-09 for ENVELLA BED manufactured by Hill-rom, Inc..
[104678531]
Patient Sequence No: 1, Text Type: N, H10
[104678532]
Baxter iv pump reflecting error code and shutting down. It was determined that the envella bed was interfering with the baxter sigma iv pumps. Manufacturer response for bed, envella bed (per site reporter). They provided information to biomed advising that the bed met all fda requirements and that the issue was with the iv pump.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7406606 |
| MDR Report Key | 7406606 |
| Date Received | 2018-04-09 |
| Date of Report | 2018-03-21 |
| Date of Event | 2018-03-14 |
| Report Date | 2018-03-21 |
| Date Reported to FDA | 2018-03-21 |
| Date Reported to Mfgr | 2018-03-21 |
| Date Added to Maude | 2018-04-09 |
| 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 |
| 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 BED |
| Generic Name | BED, AIR FLUIDIZED |
| Product Code | INX |
| Date Received | 2018-04-09 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-04-09 |