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

Model Number 14060

Device Problem Pumping Problem (3016)

Patient Problem Pressure Sores (2326)

Event Date 01/15/2024

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 337553723
• Report Number: 2438477-2024-00014
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 00822383118277
• UDI-Public: 822383118277
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Report Sent to FDA: 03/13/2024
• Distributor Facility Aware Date: 02/15/2024
• Event Location: Home
• Date Report to Manufacturer: 03/13/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 60 YR
• Patient Sex: Male