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

Model Number 14530

Device Problem Mechanical Problem (1384)

Patient Problem Skin Erosion (2075)

Event Date 08/09/2022

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 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
• Type of Device: 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
• MDR Text Key: 330902637
• Report Number: 2438477-2023-00149
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 00822383932187
• UDI-Public: 00822383932187
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Model Number: 14530
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/19/2023
• Distributor Facility Aware Date: 08/09/2022
• Event Location: Home
• Date Report to Manufacturer: 12/19/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female