MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-08 for ENVISION E700 WOUND SURFACE P741A manufactured by Hill-rom, Inc.
[82030060]
Patient Sequence No: 1, Text Type: N, H10
[82030061]
A customer with multiple skin issues was on an envision mattress that continued to malfunction. Hill rom was notified and a technician came to the customer's bedside and reported that there were no replacement envision mattresses available at the time. Staff have reported on numerous alarms that do not allow the envision mattresses to function properly and that hill rom technicians are unable to resolve any of the issues with mattresses not working properly. Unfortunately, the details of these events are very vague. Hill rom was notified and is reviewing issues and why the technicians were unable to resolve them. Hill rom's review and determination was reported back as follows: "there are times that the blower will display an error code. Sometimes there is not truly a repair on the mattress, but rather just arrest of the blower. The mattress will continue to provide the therapy required during this time, but attention is needed as to why the error code is appearing on the blower. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6773258 |
| MDR Report Key | 6773258 |
| Date Received | 2017-08-08 |
| Date of Report | 2017-08-03 |
| Date of Event | 2017-05-31 |
| Report Date | 2017-07-14 |
| Date Reported to FDA | 2017-07-14 |
| Date Reported to Mfgr | 2017-07-14 |
| Date Added to Maude | 2017-08-08 |
| 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 | ENVISION E700 WOUND SURFACE |
| Generic Name | MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE |
| Product Code | IOQ |
| Date Received | 2017-08-08 |
| Returned To Mfg | 2017-05-31 |
| Model Number | E700 |
| Catalog Number | P741A |
| Device Availability | R |
| 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 | 2017-08-08 |