MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-12-22 for HOVERMATT LATERAL PATIENT TRANSFER DEVICE HM34HS manufactured by D.t. Davis Enterprises Ltd., Hovertech Intl.
[1683655]
The dialysis unit was using a hovermatt with the (b)(4) pump on an in-patient with an (b)(4). The staff had the motor running at low pressure to relieve the discomfort for the pt. The staff had lowered the side rail on the stretcher and left the pt unattended. When the resident shifted his weight with the motor running at low pressure the hovermatt was inflated enough to have him slip off the stretcher. Narrative was taken directly from the hospital description form: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[8926762]
The label on the hovermatt clearly states: "do not leave pt unattended on inflated hovermatt. " the incident was caused by staff error, the pt was left unattended while the hovermatt was still inflated. According to the hospital description form the staff has been retrained by the facility key operators. The individual interviewed did state that it was a nursing error, leaving the pump running, the side rail down, and leaving the pt unattended.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2531468-2010-00002 |
| MDR Report Key | 1942917 |
| Report Source | 07 |
| Date Received | 2010-12-22 |
| Date of Report | 2010-12-13 |
| Date of Event | 2010-11-25 |
| Date Mfgr Received | 2010-12-02 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SUSAN PAVELKO |
| Manufacturer Street | 513 S. CLEWELL ST. |
| Manufacturer City | BETHLEHEM PA 18015 |
| Manufacturer Country | US |
| Manufacturer Postal | 18015 |
| Manufacturer Phone | 8004712776 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| 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 | 2010-12-22 |
| Model Number | HM34HS |
| Catalog Number | HM34HS |
| Lot Number | NA |
| ID Number | NA |
| 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., HOVERTECH INTL |
| Manufacturer Address | BETHLEHEM PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2010-12-22 |