MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-03 for HOVERMATT LATERAL TRANSFER MATTRESS HM34SPU manufactured by D.t. Davies Enterprises Ltd.
[37341487]
Patient Sequence No: 1, Text Type: N, H10
[37341488]
Patient's head was slipping out of the bed in the middle of the laparoscopy procedure in thirty degree trendelenburg lithotomy position. The straps were secured on allen stirrups. A half size hovermatt mattress was used. Anesthesiologist placed gellroll/towels under the neck and head to maintain neutral position immediately supporting the head. The procedure was completed without injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5406375 |
| MDR Report Key | 5406375 |
| Date Received | 2016-02-03 |
| Date of Report | 2016-01-28 |
| Date of Event | 2016-01-13 |
| Report Date | 2016-01-19 |
| Date Reported to FDA | 2016-01-19 |
| Date Reported to Mfgr | 2016-01-19 |
| Date Added to Maude | 2016-02-03 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOVERMATT LATERAL TRANSFER MATTRESS |
| Generic Name | DEVICE, PATIENT TRANSFER, POWERED |
| Product Code | FRZ |
| Date Received | 2016-02-03 |
| Model Number | HM34SPU |
| Device Availability | N |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | D.T. DAVIES ENTERPRISES LTD |
| Manufacturer Address | 513 S. CLEWELL ST BETHLEHEM PA 18015 US 18015 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-03 |