MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-01-10 for HOVERMATT LATERAL PATIENT TRANSFER DEVICE HM34HS manufactured by D.t. Davis Enterprises Ltd: T/a Hovertech International.
[15206853]
It was confirmed that patient sustained an orbital fracture.
Patient Sequence No: 1, Text Type: D, B5
[15798273]
D. T. Davis enterprises/hovertech was initially contacted by a biomed technician for (b)(4) hospital on 12/12/2011. He needed a copy of an air supply manual to evaluate a hovermatt and air supply that was involved in an incident. He stated that the patient was dropped while left unattended on an inflated hovermatt. The label on the hovermatt clearly states "never leave patient unattended on an inflated hovermatt air transfer system. " the biomed department was testing the devices to ensure that they worked properly. I emailed him a copy of our manual and asked who i should contact to get more information about the incident and patient condition. I contacted the (b)(6). (b)(6) returned my call on 12/15/2011 and said she would check into the matter. She called me back to let me know that their testing verified that the hovermatt and air supply were functioning properly and were not the cause of the incident. The patient had sustained an orbital fracture but was doing well. She did not have a serial number for either device. I e-mailed her a copy of the reporting form to get additional information. The form was never returned. On 12/19/2011 (b)(6), device reporting analyst, left a message. She stated that based on the information that the facility had they would not make a report to d. T. Davis enterprises/hovertech, nor to the fda. Their testing showed that the hovermatt was not the issue and they were working on other avenues. I called (b)(6) back to discuss this report and let her know that we could send a hovertech representative to retrain the staff on using the hovermatt. I have not received a return phone call. All testing was performed by the facility. The device was not returned to manufacturer for evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2531468-2011-00004 |
| MDR Report Key | 2418301 |
| Report Source | 05 |
| Date Received | 2012-01-10 |
| Date of Report | 2012-01-10 |
| Date Mfgr Received | 2011-12-12 |
| Date Added to Maude | 2012-07-30 |
| 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 | 0 |
| Event Location | 0 |
| 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 |
| 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 | 2012-01-10 |
| Model Number | HM34HS |
| Catalog Number | HM34HS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | D.T. DAVIS ENTERPRISES LTD: T/A HOVERTECH INTERNATIONAL |
| Manufacturer Address | 513 S. CLEWELL ST. BETHLEHEM PA 18015 US 18015 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-01-10 |