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

Model Number 14530

Device Problem Installation-Related Problem (2965)

Patient Problem Ulcer (2274)

Event Date 04/01/2023

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 initial reporter indicated that the provider of the pressure prevention matttress did not set up the mattress correctly and the user developed a stage 4 pressure ulcer.There was no report of any device defect, other than the improper set up.Drive did not receive any information regarding the patient's overall pressure injury management program.The product is involved in litigation between the initial reporter and the provider, and will not be returned.

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 initial reporter indicated that the provider of the pressure prevention matttress did not set up the mattress correctly and the user developed a stage 4 pressure ulcer.There was no report of any device defect, other than the improper set up.Drive did not receive any information regarding the patient's overall pressure injury management program.The product is involved in litigation between the initial reporter and the provider, and will not be returned.

• Brand Name: DRIVE
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): AIRFLO (XIAMEN) MEDICAL CO., LTD.; 1f, 3f, 4f, no. 6; east haijing road; haicang, xiamen fujian 36102 6; CH 361026
• MDR Report Key: 17840043
• MDR Text Key: 324549859
• Report Number: 2438477-2023-00129
• 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,Followup
• Report Date: 09/28/2023,10/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 14530
• Device Catalogue Number: 14530
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/28/2023
• Distributor Facility Aware Date: 08/29/2023
• Event Location: Other
• Date Report to Manufacturer: 09/28/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 87 YR
• Patient Sex: Female