MAUDE Adverse Event Report: AIRFLO (XIAMEN) MEDICAL CO., LTD. DRIVE; MATTRESS

Model Number	14029DP
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Type of Reportable Event	Malfunction
Event or Problem Description
Drive devilbiss healthcare was notified of a complaint involving a pressure prevention mattress where the provider reported that the mattress is "not getting firm enough and the patient is bottoming out and developing wounds." the patient required wound care services by a physician.The product was returned to drive and the investigation is not yet complete.

• Brand Name: DRIVE
• Common Device Name: MATTRESS
• Manufacturer (Section D): AIRFLO (XIAMEN) MEDICAL CO., LTD.; 1f, 3f, 4f, 6, e haijin rd; haicang; xiamen, fujian 36102 6; CH 361026
• MDR Report Key: 17716663
• Report Number: 2438477-2023-00120
• Device Sequence Number: 2250810
• Product Code: FNM
• UDI-Device Identifier: 00822383117164
• UDI-Public: 822383117164
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/09/2023
• Report Date (Section F): 09/09/2023

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: Lay User/Patient
• Device Model Number: 14029DP
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/09/2023
• Device Age: 6 MO
• Date Report to Manufacturer: 09/09/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/09/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 09/09/2023