MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2015-12-08 for HOVERMATT UNKNOWN manufactured by D.t. Davis Enterprises, Ltd T/a Hovertech Int.
[32958391]
Hovertech was not notified of the incident until report was received from the fda. The device involved in the incident was never returned to hovertech international, and there was no model number, lot number or serial number recorded from the suspect device by the facility. After further investigation at the facility, they found: patient had been on the hovermatt during surgery and in lithotomy position. Patient was also put into steep trendelenburg position. At the time, the patient then began to slip downward and the staff present felt that the slippage was due to the hovermatt. The follow up investigation indicated that there may have been an angel slider beneath the hovermatt, which should not have been used. There had been in-services on the use of the hovermatt since this date in (b)(6). The facility is also starting to use a different product called a steep trendelenburg positioning device and in-services have begun. There was no negative impact on the patient due to this incident. Staff has been retrained on use of the hovermatt. It does not appear that the hovermatt was the cause of the incident.
Patient Sequence No: 1, Text Type: N, H10
[32958392]
Hovermatt was in place on the operating room table when the patient was placed in lithotomy position, prepped, and draped for surgical procedure. When the table was placed in trendelenburg, there was an observed lippage towards the head of the table. The plastic material component of the hovermatt was thought to be the cause of the slippage. The hovermatt had to be removed from the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2531468-2015-00001 |
| MDR Report Key | 5275016 |
| Report Source | USER FACILITY |
| Date Received | 2015-12-08 |
| Date of Report | 2015-12-04 |
| Date of Event | 2015-04-18 |
| Report Date | 2015-09-30 |
| Date Reported to FDA | 2015-09-30 |
| Date Mfgr Received | 2015-11-09 |
| Date Added to Maude | 2015-12-08 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS SUSAN PAVELKO |
| Manufacturer Street | 513 SOUTH CLEWELL STREET |
| Manufacturer City | BETHLEHEM PA 18015 |
| Manufacturer Country | US |
| Manufacturer Postal | 18015 |
| Manufacturer Phone | 6106949600 |
| Manufacturer G1 | D.T. DAVIS ENTERPRISES, LTD T/A HOVERTECH INT |
| 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 | 2015-12-08 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | D.T. DAVIS ENTERPRISES, LTD T/A HOVERTECH INT |
| Manufacturer Address | 513 SOUTH CLEWELL STREET BETHLEHEM PA 18051 US 18051 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-12-08 |