MAUDE Adverse Event Report: D.T. DAVIS ENTERPRISES LTD. DBA HOVERTECH INTERNATIONAL HOVERMATT SPU TRANSFER AND REPOSITIONING DEVICE; DEVICE, PATIENT TRANSFER, POWERED

Model Number	HM39SPU-B
Health Effect - Clinical Code	Fall (1848)
Date of Event	07/22/2019
Type of Reportable Event	Malfunction
Event or Problem Description
At end of case, patient was transferred from or table to gurney via hovermat with the direction of anesthesiologist.There were also two rn's and anesthesia resident helping with transfer.The hovermat was inflated and patient was moved to gurney.The hovermat was pressed to deflate after transfer to gurney.After deflation, the patient was on gurney but slowly fell to his right side off of gurney.Patient was lifted back to bed by staff.Device deflated asymmetrically causing sliding.

• Brand Name: HOVERMATT SPU TRANSFER AND REPOSITIONING DEVICE
• Common Device Name: DEVICE, PATIENT TRANSFER, POWERED
• Manufacturer (Section D): D.T. DAVIS ENTERPRISES LTD. DBA HOVERTECH INTERNATIONAL; 4482 innovation way; allentown PA 18109
• MDR Report Key: 9134533
• Report Number: 9134533
• Device Sequence Number: 3186006
• Product Code: FRZ
• UDI-Device Identifier: 00816299010800
• UDI-Public: (01)00816299010800(10)19031113
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/04/2019
• Report Date (Section F): 09/04/2019

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: No Information
• Device Model Number: HM39SPU-B
• Device Catalogue Number: HM39SPU-B
• Device Lot Number: 1903111393
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/30/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/30/2019
• Patient Sequence Number: 1
• Date Report Sent to FDA: 09/04/2019