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

Model Number 14026

Device Problem Use of Incorrect Control/Treatment Settings (1126)

Patient Problem Ulcer (2274)

Event Date 01/17/2022

Event Type  Injury  

Event 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 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
• Type of Device: 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
• MDR Text Key: 290941202
• Report Number: 2438477-2022-00008
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 00822383973661
• UDI-Public: 822383973661
• 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,Followup
• Report Date: 03/07/2022,03/03/2022

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: Health Professional
• Device Model Number: 14026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/07/2022
• Distributor Facility Aware Date: 01/24/2022
• Device Age: 5 MO
• Event Location: Home
• Date Report to Manufacturer: 03/08/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/03/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/08/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 73 KG