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

Model Number	14060
Medical Device Problem Code	Pumping Problem (3016)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	01/15/2024
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 end user's home health nurse reported that the pump to the mattress was alarming several times a day for low pressure.She reported that the provider of the mattress was notified and made multiple service calls.The end user developed a pressure sore and was admitted to the hospital for debridement.The end user has since been released from the hospital.It is unclear when the pressure sore began to develop, or what other elements of the pressure injury management program were implemented.The mattress and pump were discarded and cannot be evaluated.Drive devilbiss is investigating the incident, and 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; jen ai road, taipei 10056 ; TW 10056
• MDR Report Key: 18894661
• Report Number: 2438477-2024-00014
• Device Sequence Number: 6410804
• Product Code: FNM
• UDI-Device Identifier: 00822383118277
• UDI-Public: 822383118277
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/13/2024
• Report Date (Section F): 03/13/2024

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: 14060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/15/2024
• Event Location: Home
• Date Report to Manufacturer: 03/13/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/13/2024
• 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: Hospitalization
• Patient Age: 60 YR
• Patient Sex: Male
• Date Report Sent to FDA: 03/13/2024