MAUDE Adverse Event Report: GRAND HEALTHCARE CO. LTD DRIVE DEVILBISS MED AIRE LOW AIR PRESSURE PREVENTION; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number	14027
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	07/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified by an end user 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 the top cells of the mattress are leaking.The end user has been using the mattress for three months while the bed was leaking.He has reportedly developed a bed sore on his back from laying against the hard bed frame.The end user's home nurse has been treating the wound.As part of its complaint review and evaluation process, drive devilbiss healthcare will also notify the manufacturer of the product about this complaint.

• Brand Name: DRIVE DEVILBISS MED AIRE LOW AIR PRESSURE PREVENTION
• Common Device Name: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): GRAND HEALTHCARE CO. LTD; 4 f., no. 49, sec. 2, ren'ai r; zhongzheng dist.; taipei city, taipei 10056 ; TW 10056
• MDR Report Key: 22577797
• Report Number: 2438477-2025-00032
• Device Sequence Number: 18553570
• Product Code: FNM
• UDI-Device Identifier: 00822383221618
• UDI-Public: (01)00822383221618
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 07/23/2025
• Report Date (Section F): 07/23/2025

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
• Device Catalogue Number: 14027
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/01/2025
• Event Location: Home
• Date Report to Manufacturer: 07/23/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/23/2025
• 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: 62 YR
• Patient Sex: Male
• Date Report Sent to FDA: 07/23/2025