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

Model Number	14027
Medical Device Problem Code	Dent in Material (2526)
Health Effect - Clinical Code	Ulcer (2274)
Date of Event	02/16/2022
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: 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
• Report Number: 2438477-2022-00028
• Device Sequence Number: 20425726
• Product Code: FNM
• UDI-Device Identifier: 00822383221618
• UDI-Public: 822383221618
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 04/13/2022
• Report Date (Section F): 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
• Operator of Device: Lay User/Patient
• Device Model Number: 14027
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/16/2022
• Device Age: 2 YR
• Event Location: Home
• Date Report to Manufacturer: 04/18/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/13/2022
• 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 Age: 37 YR
• Patient Sex: Male
• Patient Weight: 54 KG
• Date Report Sent to FDA: 04/13/2022