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

Model Number 14027

Device Problem Dent in Material (2526)

Patient Problem Ulcer (2274)

Event Date 02/16/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, drive devilbiss healthcare was notified of an incident regarding an alternating pressure and low air loss mattress system, which is intended to be used as one component of a comprehensive, multi-disciplinary pressure injury management program.The end user reported that the mattress system, which is used by her son, who is paralyzed, was sinking in the center cells.A replacement pump was provided, but it did not resolve the issue.She stated that her son "is now developing a lot of bed sores due to this." drive has yet to receive any information regarding the patient's overall pressure injury management program.Drive will continue to investigate the incident.

• Brand Name: DRIVE
• Type of Device: PRESSURE PREVENTION 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: 14106170
• MDR Text Key: 289536236
• Report Number: 2438477-2022-00028
• 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: 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 14027
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/13/2022
• Distributor Facility Aware Date: 02/16/2022
• Device Age: 2 YR
• Event Location: Home
• Date Report to Manufacturer: 04/18/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/13/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 37 YR
• Patient Sex: Male
• Patient Weight: 54 KG