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

Model Number	14530
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Skin Erosion (2075)
Date of Event	08/09/2022
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 reporter reported that the mattress is "going flat," causing the end user's preexisting bed sores to become worse.The reporter did not provide any other details of the end user's pressure injury management program, or any information regarding medical treatment of the exacerbation.An update will be filed if additional information becomes available.

• Brand Name: DRIVE DEVILBISS HEALTHCARE
• Common Device Name: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): GRAND HEALTHCARE CO., LTD; 4f no. 49 sec. 2 jenai road; taipei, taipei ; TW
• MDR Report Key: 18358258
• Report Number: 2438477-2023-00149
• Device Sequence Number: 20811489
• 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
• Report Date (Section B): 12/19/2023
• Report Date (Section F): 12/19/2023

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 14530
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/09/2022
• Event Location: Home
• Date Report to Manufacturer: 12/19/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/19/2023
• 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 Sex: Female
• Date Report Sent to FDA: 12/19/2023