MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-12-22 for HOVERMATT manufactured by D.t. Davis Enterprises Ltd..
[5424242]
Reference uf/importer # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[12864213]
On (b)(6) 2014, hovertech's quality manager learned of the incident of the patient falling out of bed with injury. At this time we believed this to be a 30 day report. Manufacturer was informed of the status of the patient at a much later date. The report from (b)(6) was not received until (b)(6) 2014. No cause of death was recorded. The manufacturer's report has been sent to the fda within 5 days of being notified of the patient's passing. There is no information in the facility report that indicates the uninflated hovermatt (lateral transfer device) contributed to the patient fall and subsequent injuries: the lateral transfer device was not in use when the incident occurred. ; the patient had been sleeping on the uninflated lateral transfer device. ; only 3 of the 4 bed rails were employed when the incident occurred. ; hovertech's instructions for use provided according to regulation on the equipment and in the user's manual clearly state that the bed rails should be raised after the hovermatt is deflated. We are coordinating retraining with the facility.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2531468-2014-00001 |
| MDR Report Key | 4449582 |
| Report Source | 06 |
| Date Received | 2014-12-22 |
| Date Mfgr Received | 2014-11-21 |
| Date Added to Maude | 2015-01-27 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 513 S. CLEWELL ST. |
| Manufacturer City | BETHLEHEM PA 18020 |
| Manufacturer Country | US |
| Manufacturer Postal | 18020 |
| Manufacturer Phone | 8004172776 |
| Single Use | 3 |
| Remedial Action | OT |
| 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 | 2014-12-22 |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | D.T. DAVIS ENTERPRISES LTD. |
| Manufacturer Address | 513 S. CLEWELL ST. BETHLEHEM PA 18015453 US 18015 4537 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-22 |