MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2010-06-17 for HOVERMATT LATERAL PATIENT TRANSFER DEVICE HM34HS manufactured by D.t. Davis Enterprises Ltd..
[1634963]
Two caregivers were using a hovermatt to transfer a patient from a hospital bed to an air mattress. Once the patient was over on the new bed, the hovermatt suddenly popped out from under the patient and pushed the patient to the edge of the bed and the patient fell in between the two beds onto the floor.
Patient Sequence No: 1, Text Type: D, B5
[8640679]
Add'l mfr date: 08/16/2007. We, d. T. Davis enterprises, were notified of the incident on (b)(6) 2010. Two hovermatts were on trial at the facility where the incident occurred. Training was provided by our sales representative, before the hovermatts were put into service at (b)(6). Upon notification of the incident, both hovermatts were removed from use by our sales representative. The matts were returned to the us on (b)(6) 2010 and (b)(6) was contacted for additional information. The clinical manager supplied the information included in this report on (b)(6) 2010. It is uncertain which one of the hovermatts was involved in the incident, so both matts were inspected and functionally tested per our quality assurance procedure. When tested, both hovermatts functioned properly and no defects were found. The reported incident could not be duplicated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2531468-2010-00001 |
| MDR Report Key | 1740722 |
| Report Source | 05,07 |
| Date Received | 2010-06-17 |
| Date of Report | 2010-06-16 |
| Date of Event | 2010-05-16 |
| Date Facility Aware | 2010-05-16 |
| Report Date | 2010-06-16 |
| Date Mfgr Received | 2010-05-17 |
| Device Manufacturer Date | 2007-03-31 |
| Date Added to Maude | 2012-03-15 |
| 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 | 3 |
| Manufacturer Contact | SUSAN PAVELKO |
| Manufacturer Street | 513 SOUTH CLEWELL STREET |
| 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 | 2010-06-17 |
| Returned To Mfg | 2010-06-09 |
| Model Number | HM34HS |
| Catalog Number | HM34HS |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | D.T. DAVIS ENTERPRISES LTD. |
| Manufacturer Address | 513 SOUTH CLEWELL STREET T/A HOVERTECH INTERNATIONAL BETHLEHEM PA 18015 US 18015 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2010-06-17 |