MAUDE Adverse Event Report: APEX MEDICAL CORP DRIVE DEVILBISS HEALTHCARE; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number	14200
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	07/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) 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 mother of the end-user reported that the mattress "had been low for a while" and had noticed this when rotating him in the bed.The mother indicated that the tubing had disintegrated where it attaches to the pump, and she tried to fix it by using clamps and duct tape.The mother reported that her son developed a new pressure sore in the groin area that is requiring debridement.As part of its complaint review and evaluation process, (b)(6) healthcare will also notify the manufacturer of the product about this complaint.

• Brand Name: DRIVE DEVILBISS HEALTHCARE
• Common Device Name: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): APEX MEDICAL CORP; 921 e amidon st; sioux falls SD 57104 0909
• MDR Report Key: 20273244
• Report Number: 2438477-2024-00049
• Device Sequence Number: 7419032
• Product Code: FNM
• UDI-Device Identifier: 00822383565866
• UDI-Public: 00822383565866
• 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): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/20/2024
• Report Date (Section F): 09/20/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 14200
• Device Catalogue Number: 14200
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/22/2024
• Event Location: Home
• Date Report to Manufacturer: 09/20/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/20/2024
• 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 Sex: Male
• Date Report Sent to FDA: 09/20/2024