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

Model Number	14027
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Type of Reportable Event	Malfunction
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a pressure prevention mattress, which is intended to be used as one component of a comprehensive, multi-disciplinary pressure injury management program.The end user of the mattress stated "the mattress deflates in 5 mins after inflating," but he "cannot find a leak in the mattress." he reported that he is "starting to develop bed sores." drive did not receive any information regarding the patient's overall pressure injury management program.The end user requested a replacement and did not return the product to drive.

• 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: 16294317
• Report Number: 2438477-2023-00005
• Device Sequence Number: 6453927
• Product Code: FNM
• UDI-Device Identifier: 00822383221618
• UDI-Public: 822383221618
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/02/2023
• Report Date (Section F): 02/02/2023

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: 14027
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/17/2023
• Device Age: 1 YR
• Date Report to Manufacturer: 02/09/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/03/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/02/2023