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

Model Number 14029DP

Device Problem Unintended Deflation (4061)

Patient Problem Tissue Breakdown (2681)

Event Type  malfunction  

Event 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
• 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: 17716663
• MDR Text Key: 323040905
• Report Number: 2438477-2023-00120
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 00822383117164
• UDI-Public: 822383117164
• 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: 09/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 14029DP
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/09/2023
• Distributor Facility Aware Date: 09/09/2023
• Device Age: 6 MO
• Date Report to Manufacturer: 09/09/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other