MAUDE Adverse Event Report: D.T. DAVIS ENTERPRISES LTD. HOVERMATT; DEVICE, PATIENT TRANSFER, POWERED

Model Number	HM34HS
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/31/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Nurse said patient needed to be on a stretcher and should be slid over to the stretcher.Transporters rolled patient from side to side to place the reusable hovermatt under patient.The stretcher was placed alongside the bed.Transporters inflated the hovermatt and slowly slid the patient over in the direction of the stretcher.While sliding the hovermatt over on to the stretcher it seemed to meet some resistance in the sound of it's inflation and then gain it back.The patient was in the middle of the stretcher.Transporters agreed he was set on the stretcher and moved to turn off canister and deflate the hovermatt.Suddenly the patient and hovermatt started moving toward the edge of the bed and the top half of the matt with patient slid to the ground.Patients feet remained on the stretcher.Hovermatt remained inflated and patient denies striking head or any injury.Hovermatt removed from service.

• Brand Name: HOVERMATT
• Common Device Name: DEVICE, PATIENT TRANSFER, POWERED
• Manufacturer (Section D): D.T. DAVIS ENTERPRISES LTD.; 4482 innovation way; allentown PA 18109
• MDR Report Key: 7921762
• Report Number: 7921762
• Device Sequence Number: 16525505
• Product Code: FRZ
• UDI-Device Identifier: 00816299010053
• UDI-Public: (01)00816299010053
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/19/2018
• Report Date (Section F): 09/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: HM34HS
• Device Catalogue Number: HM34HS
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/01/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 09/24/2018