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

Model Number	14530
Medical Device Problem Code	Installation-Related Problem (2965)
Health Effect - Clinical Code	Ulcer (2274)
Date of Event	04/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of a complaint involving a pressure prevention mattress, which is intended to be used as one component of a comprehensive, multi-disciplinary pressure injury management program.The initial reporter indicated that the provider of the pressure prevention matttress did not set up the mattress correctly and the user developed a stage 4 pressure ulcer.There was no report of any device defect, other than the improper set up.Drive did not receive any information regarding the patient's overall pressure injury management program.The product is involved in litigation between the initial reporter and the provider, and will not be returned.
Event or Problem Description
Drive devilbiss healthcare was notified of a complaint involving a pressure prevention mattress, which is intended to be used as one component of a comprehensive, multi-disciplinary pressure injury management program.The initial reporter indicated that the provider of the pressure prevention matttress did not set up the mattress correctly and the user developed a stage 4 pressure ulcer.There was no report of any device defect, other than the improper set up.Drive did not receive any information regarding the patient's overall pressure injury management program.The product is involved in litigation between the initial reporter and the provider, and will not be returned.

• Brand Name: DRIVE
• Common Device Name: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): AIRFLO (XIAMEN) MEDICAL CO., LTD.; 1f, 3f, 4f, no. 6; east haijing road; haicang, xiamen fujian 36102 6; CH 361026
• MDR Report Key: 17840043
• Report Number: 2438477-2023-00129
• Device Sequence Number: 18006505
• Product Code: FNM
• UDI-Device Identifier: 00822383932187
• UDI-Public: 00822383932187
• Combination Product (Y/N): N
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2023
• Report Date (Section F): 09/28/2023

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: 14530
• Device Catalogue Number: 14530
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/29/2023
• Event Location: Other
• Date Report to Manufacturer: 09/28/2023
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/28/2023
• Supplement Report FDA Received Date: 10/16/2023
• 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: 87 YR
• Patient Sex: Female
• Date Report Sent to FDA: 09/28/2023