MAUDE Adverse Event Report: AIRFLO (XIAMEN) MEDICAL CO., LTD. DRIVE; MATTRESS

Model Number 14027

Device Problem Inflation Problem (1310)

Patient Problem Pressure Sores (2326)

Event Date 07/01/2022

Event Type  Injury  

Event Description

Drive devilbiss healthcare was notified 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's daughter stated that "the unit had a deflated bladder, and the end user is starting to develop bed sores." drive did not receive any information regarding the patient's overall pressure injury management program.The end user discarded the unit and is unable to return to drive for an evaluation.Drive is currently investigating the incident and will file an update if additional information becomes available.

• Brand Name: DRIVE
• Type of Device: MATTRESS
• Manufacturer (Section D): AIRFLO (XIAMEN) MEDICAL CO., LTD.; 1f, 3f, 4f, 6, e haijin rd; haicang; xiamen, fujian 36102 6; CH 361026
• MDR Report Key: 16724010
• MDR Text Key: 313142171
• Report Number: 2438477-2023-00026
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 00822383221618
• UDI-Public: 00822383221618
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 14027
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/12/2023
• Distributor Facility Aware Date: 03/16/2023
• Date Report to Manufacturer: 04/19/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 86 KG