MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 2013-06-24 for HOVERMATT LATERAL PATIENT TRANSFER DEVICE HM34HS manufactured by D.t. Davis Enterprises, Ltd: T/a Hovertech International.
[18810186]
Pt fell while being transferred from a hospital bed to a transport stretcher using a hovermatt mattress. During the transfer, the pt restraining straps tore away from the mattress. The employees inflated the hovermatt and laterally transferred the pt from the bed to the stretcher. The hovermatt straps were intact and secured during the transfer. Once the pt was on the stretcher, one of the employees attempted to raise the outside side rail while the hovermatt was still inflated. The stretcher moved slightly and the hovermatt slid off the stretcher. One of the employees grabbed the upper strap to prevent the hovermatt and pt from falling. The right upper strap was pulled off when the employee grabbed it. The strap did not rip apart from the mattress, the threads were torn. Mattress serial number model number hm34hs.
Patient Sequence No: 1, Text Type: D, B5
[19062792]
The fda report was received by hovertech on (b)(4) 2013. The facility never reported the incident to d. T. Davis enterprises. (b)(6) was contacted on (b)(4) 2013 and a message was left; a follow-up e-mail was sent. (b)(6) returned the call on (b)(6) 2013. (b)(6) stated that despite the fact, the report stated the pt fell, this was not the case. The pt did not fall and there were no injuries due to the incident with the hovermatt. A strap tore away from the top of the hovermatt but remained intact. The employee pulled the pt safety strap to prevent the pt from falling. Since the stitching tore, the hovermatt was removed from service and placed in (b)(6)'s office. He said the matt would be returned to hovertech for review and he would help fill in the missing information. No reply was received and the device was not returned at this time. The manuel states, "pt safety straps (2) do not use to transfer. " the pt safety straps are to secure the pt on the hovermatt, they are not meant for transferring/pulling. Since the hovermatt was not returned, a full eval could not be completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2531468-2013-00001 |
| MDR Report Key | 3198486 |
| Report Source | 00,06 |
| Date Received | 2013-06-24 |
| Date of Report | 2013-06-21 |
| Date of Event | 2013-04-26 |
| Date Facility Aware | 2013-04-26 |
| Report Date | 2013-06-21 |
| Date Mfgr Received | 2013-05-20 |
| Date Added to Maude | 2013-07-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 513 S. CLEWELL ST. |
| Manufacturer City | BETHLEHEM PA 18015 |
| Manufacturer Country | US |
| Manufacturer Postal | 18015 |
| Manufacturer Phone | 8004712776 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOVERMATT LATERAL PATIENT TRANSFER DEVICE |
| Generic Name | DEVICE, PATIENT TRANSFER, POWERED |
| Product Code | FRZ |
| Date Received | 2013-06-24 |
| Model Number | HM34HS |
| Catalog Number | HM34HS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | D.T. DAVIS ENTERPRISES, LTD: T/A HOVERTECH INTERNATIONAL |
| Manufacturer Address | 513 S. CLEWELL ST. BETHLEHEM PA 18015 US 18015 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-06-24 |