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

Model Number 14027

Device Problem Inflation Problem (1310)

Patient Problem Pressure Sores (2326)

Event Type  malfunction  

Event 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
• Type of Device: 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
• MDR Text Key: 308753047
• Report Number: 2438477-2023-00005
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 00822383221618
• UDI-Public: 822383221618
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Model Number: 14027
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/02/2023
• Distributor Facility Aware Date: 01/17/2023
• Device Age: 1 YR
• Date Report to Manufacturer: 02/09/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/03/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1