MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2012-09-18 for HOVERMATT LATERAL PATIENT TRANSFER DEVICE HM34HS manufactured by D.t. Davis Enterprises Ltd. T/a Hovertech International.
[3041378]
(b)(6) was dropped to the floor while being transferred from hospital bed to x-ray table 3 days after having bilateral hip replacement. Could have been operator error or equipment failure. Damage to left hip resulting in being in hospital a month longer than expected, and needing two extra operations. " the equipment failure mentioned above is that of the hospital bed brakes.
Patient Sequence No: 1, Text Type: D, B5
[10209326]
As stated in the report from (b)(6): "after the initial investigation it appears that either proper pt transfer protocols which require hospital bed brakes to be applied before a transfer commences were not adhered to, or that the brakes on the bed were faulty. " it also states in the hovermatt instructions for use; "ensure the transfer surfaces are as close as possible, and brake the wheels. " conclusion: it would appear that either proper pt transfer protocols which require the hospital bed brakes to be applied before a transfer commences were not adhered to, or that the brakes on the bed were faulty. My investigation also found that the hovermatt was operating correctly at the time of the incident and was inflated firmly though to support the pt as they fell. It was also said that the hovermatt had in fact saved the patent from receiving a much worse injury. If the pt had been on any other transfer device, they would have fallen directly onto the floor.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2531468-2012-00002 |
| MDR Report Key | 2781990 |
| Report Source | 01,08 |
| Date Received | 2012-09-18 |
| Date of Report | 2012-09-17 |
| Date of Event | 2012-04-26 |
| Date Facility Aware | 2012-08-20 |
| Report Date | 2012-09-17 |
| Date Mfgr Received | 2012-08-21 |
| Date Added to Maude | 2012-10-12 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 513 S. CLEWELL ST |
| Manufacturer City | BETHLEHEM PA 18015 |
| Manufacturer Country | US |
| Manufacturer Postal | 18015 |
| Manufacturer Phone | 6106949600 |
| Single Use | 3 |
| Remedial Action | OT |
| 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 | 2012-09-18 |
| Model Number | HM34HS |
| Catalog Number | HM34HS |
| Lot Number | NA |
| Device Availability | N |
| Device Age | 1 YR |
| 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 | 1. Hospitalization | 2012-09-18 |