MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-25 for ZEPHYR PATIENT POSITIONING AND TRANSFER BED ZEP-2 manufactured by Diacor, Inc..
[83636213]
Patient Sequence No: 1, Text Type: N, H10
[83636214]
Patient sustained third degree burn from skin contact with bar on zephyr transport and positioning bed. Manufacturer response for patient bed, zephyr bed (per site reporter). Manufacturer was advised immediately of the incident. They have submitted followup questions about the incident. I am unaware of any other intervention by manufacturer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6820181 |
| MDR Report Key | 6820181 |
| Date Received | 2017-08-25 |
| Date of Report | 2017-03-31 |
| Date of Event | 2017-02-06 |
| Report Date | 2017-03-30 |
| Date Reported to FDA | 2017-03-30 |
| Date Reported to Mfgr | 2017-03-30 |
| Date Added to Maude | 2017-08-25 |
| 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 | ZEPHYR PATIENT POSITIONING AND TRANSFER BED |
| Generic Name | DEVICE, PATIENT TRANSFER, POWERED |
| Product Code | FRZ |
| Date Received | 2017-08-25 |
| Model Number | ZEP-2 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DIACOR, INC. |
| Manufacturer Address | 2550 DECKER LAKE BLVD SUITE 26 WEST VALLEY CITY UT 84119 US 84119 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2017-08-25 |