MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-13 for HILL-ROM ENVELLA BED manufactured by Hill-rom.
[92094537]
Problem occurred in an acute care hospital setting. It was reported to pso that interference with intravenous infusion device and also with the portable cardiac telemetry monitoring device occurred when the new hill-rom envella specialty high fluidized therapy bed is turned on and in use. This happened with 2 different pts and 2 different envella beds. The interference interrupted an infusion of blood to the pt. Once the iv machine was moved away from the bed and faced towards the window, the pt was able to continue receiving blood transfusion. This is the second report of malfunctioning pumps where an envella is present. Hill-rom has been notified and waiting to hear their action.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5073293 |
| MDR Report Key | 7027406 |
| Date Received | 2017-11-13 |
| Date of Report | 2017-11-09 |
| Date of Event | 2017-10-31 |
| Date Added to Maude | 2017-11-14 |
| 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 | 2017-11-13 |
| Returned To Mfg | 2017-11-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HILL-ROM |
| Manufacturer Address | BATESVILLE IN US |
| Brand Name | HILL-ROM ENVELLA BED |
| Generic Name | BED, AIR FLUIDIZED |
| Product Code | INX |
| Date Received | 2017-11-13 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | HILL-ROM |
| Manufacturer Address | BATESVILLE IN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-11-13 |