MAUDE Adverse Event Report: GRAND HEALTHCARE CO. LTD DRIVE MED AIRE 8"LOWAIRLOSS.W/PUMP SYSTEM; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number	14029
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(4) was notified of an incident involving a pressure prevention mattress, which is intended to be used as one component of a comprehensive, multi-disciplinary pressure injury management program.The end user reported that every third cell is not inflating, the pump alarms for low pressure, and the end user developed a pressure sore that required treatment at a wound clinic.As part of its complaint review and evaluation process, (b)(4) will also notify the manufacturer of the product about this complaint.

• Brand Name: DRIVE MED AIRE 8"LOWAIRLOSS.W/PUMP SYSTEM
• Common Device Name: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): GRAND HEALTHCARE CO. LTD; 4f, no. 49, sec. 2; jen ai road; new taipei, taipei ; TW
• MDR Report Key: 24818717
• Report Number: 2438477-2026-00018
• Device Sequence Number: 18530795
• Product Code: FNM
• UDI-Device Identifier: 00822383110820
• UDI-Public: (01)00822383110820
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Report Date (Section B): 04/08/2026
• Report Date (Section F): 04/08/2026

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: 14029
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/20/2026
• Event Location: Home
• Date Report to Manufacturer: 04/08/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/08/2026
• 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; Other
• Patient Age: 64 YR
• Patient Sex: Unknown
• Patient Weight: 64 KG
• Date Report Sent to FDA: 04/08/2026