MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-01 for HOVERMATT LATERAL TRANSFER MATTRESS HM34SPU manufactured by D.t. Davis Enterprises Ltd.
[37192318]
Patient Sequence No: 1, Text Type: N, H10
[37192319]
Patient in operating room for laparoscopic appendectomy. The patient had been placed on hovermatt transfer mattress. The operating room table was tilted head down and to the left at the request of the surgeon. Because of the hovermatt, the patient's body started to slowly slide off of the operating room table. Surgeon and anesthesiologist, who was at the head of the table) attempted to catch the patient but he was unable to stop patient from sliding down. Surgeon had to guide the patient to the floor with himself underneath the patient to protect the patient from injury. The hovermatt was under the patient, but all of the edges had been tucked underneath the mattress. The operating room table safety straps were across the patient's thighs.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5401221 |
| MDR Report Key | 5401221 |
| Date Received | 2016-02-01 |
| Date of Report | 2016-01-28 |
| Date of Event | 2016-01-07 |
| Report Date | 2016-01-19 |
| Date Reported to FDA | 2016-01-19 |
| Date Reported to Mfgr | 2016-01-19 |
| Date Added to Maude | 2016-02-01 |
| 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 | 0 |
| 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 |
| Product Code | FRZ |
| Date Received | 2016-02-01 |
| Model Number | HM34SPU |
| Device Availability | * |
| Device Age | 1 DY |
| 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 18015 US 18015 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-01 |