MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-01 for HOVERMATT HM34HS manufactured by D.t. Davis Enterprises Ltd..
[122175721]
Nurse said patient needed to be on a stretcher and should be slid over to the stretcher. Transporters rolled patient from side to side to place the reusable hovermatt under patient. The stretcher was placed alongside the bed. Transporters inflated the hovermatt and slowly slid the patient over in the direction of the stretcher. While sliding the hovermatt over on to the stretcher it seemed to meet some resistance in the sound of it's inflation and then gain it back. The patient was in the middle of the stretcher. Transporters agreed he was set on the stretcher and moved to turn off canister and deflate the hovermatt. Suddenly the patient and hovermatt started moving toward the edge of the bed and the top half of the matt with patient slid to the ground. Patients feet remained on the stretcher. Hovermatt remained inflated and patient denies striking head or any injury. Hovermatt removed from service.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 7921762 |
MDR Report Key | 7921762 |
Date Received | 2018-10-01 |
Date of Report | 2018-09-19 |
Date of Event | 2018-08-31 |
Report Date | 2018-09-24 |
Date Reported to FDA | 2018-09-24 |
Date Reported to Mfgr | 2018-10-01 |
Date Added to Maude | 2018-10-01 |
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 | OTHER HEALTH CARE PROFESSIONAL |
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 | HOVERMATT |
Generic Name | DEVICE, PATIENT TRANSFER, POWERED |
Product Code | FRZ |
Date Received | 2018-10-01 |
Model Number | HM34HS |
Catalog Number | HM34HS |
Device Availability | N |
Device Eval'ed by Mfgr | * |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | D.T. DAVIS ENTERPRISES LTD. |
Manufacturer Address | 4482 INNOVATION WAY ALLENTOWN PA 18109 US 18109 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2018-10-01 |