MAUDE Adverse Event Report: AIRFLO (XIAMEN) MEDICAL CO., LTD. DRIVE; LOW AIR LOSS SYSTERM

Model Number	14026
Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Code	Ulcer (2274)
Date of Event	01/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss was notified on january 24, 2022, of an incident with a, rented, lowe aire pressure mattress that was provided on (b)(6).This notification was done by the patient.A second notification from the patient was received on january 31.The initial notification noted that the "mattress is deflated right down the middle and she is sunken into the bed." she reported that she "hit her cheek bone and broke it." the end-user is bed bound on a respirator and does not want to go to the hospital.She has a home health care nurse 24 hours 7 days a week and was treated by her at home.In the second notification the end-user reported that she had developed a third degree wound due to the mattress failure.On january 28, a notification was received from the service provider.In that notification, the service provider states, "i am concerned that possibly this member isn't using the correct settings on the bed".On (b)(6), the end-user confirmed that her bed sores were healing with the help of her at home nurses.We requested the return of the units on (b)(6) for evaluation.They have not been received at the time of this filing.
Event or Problem Description
On (b)(6) 2022, an end user notified drive devilbiss healthcare of an incident involving a rented lowe aire pressure mattress.The end user reported that the "mattress is deflated right down the middle and she is sunken into the bed," and that she "hit her cheek bone and broke it." because the end-user is bed bound on a respirator, she opted not to go to the hospital, but was instead treated by her 24/7 home health care nurse at home.On (b)(6), the service provider notified drive that "i am concerned that possibly this member isn't using the correct settings on the bed." the end user contacted drive again on (b)(6), and reported that she had developed a third degree pressure wound/bed sore due to the mattress failure.On february 8, the end user confirmed that her bed sores were healing with the help of her home health care nurses.We are attempting to retrieve the subject product for evaluation, and will follow up with the end user and update this report when additional information becomes available.

• Brand Name: DRIVE
• Common Device Name: LOW AIR LOSS SYSTERM
• Manufacturer (Section D): AIRFLO (XIAMEN) MEDICAL CO., LTD.; 1f, 3f, 4f, no. 6, e haijin rd; haicang; xiamen, fujian 36102 6; CH 361026
• MDR Report Key: 13660160
• Report Number: 2438477-2022-00008
• Device Sequence Number: 17421167
• Product Code: FNM
• UDI-Device Identifier: 00822383973661
• UDI-Public: 822383973661
• 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): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2022
• Report Date (Section F): 03/07/2022

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: Health Professional
• Device Model Number: 14026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/24/2022
• Device Age: 5 MO
• Event Location: Home
• Date Report to Manufacturer: 03/08/2022
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/03/2022
• Supplement Report FDA Received Date: 03/08/2022
• 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: Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Date Report Sent to FDA: 03/07/2022