MAUDE Adverse Event Report: Grand Healthcare Co. LTD Med Aire Med Aire Low Air Loss, 8in; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number	14027
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Ulcer (2274)
Type of Reportable Event	Serious Injury

• Brand Name: Med Aire Med Aire Low Air Loss, 8in
• 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: 50855088
• Report Number: 2438477-2026-00065
• Device Sequence Number: 10026423
• Product Code: FNM
• UDI-Device Identifier: 00822383221618
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/22/2026
• Report Date (Section F): 09/22/2026

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: 14027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/27/2026
• Device Age: 8 MO
• Event Location: Home
• Date Report to Manufacturer: 09/22/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/22/2026
• 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: Other; Required Intervention
• Patient Sex: Male
• Patient Weight: 215 LB
• Date Report Sent to FDA: 09/22/2026