MAUDE Adverse Event Report: EEZCARE MEDICAL CORP. MED AIRE; BARIATRIC ALTERNATING PRESSURE AND LOW AIR LOSS MATTRESS SYSTEM

Model Number	14030
Medical Device Problem Code	Decreased Pump Speed (1500)
Health Effect - Clinical Code	Ulcer (2274)
Date of Event	06/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was contacted by a distributor regarding a reported injury involving a bariatric alternating pressure and low air loss mattress system, which is intended to be used as one component of a comprehensive, multi-disciplinary pressure injury management program.The end user stated that the system's pump was defective because it "won't allow him to lock, change weight or inflate." he reported having developed pressure ulcers as a result and receiving medical treatment for them.Drive did not receive any information regarding the patient's overall pressure injury management program.Drive is currently investigating the incident, including attempting to retrieve the product to evaluate it.Drive will update this filing if additional information becomes available.

• Brand Name: MED AIRE
• Common Device Name: BARIATRIC ALTERNATING PRESSURE AND LOW AIR LOSS MATTRESS SYSTEM
• Manufacturer (Section D): EEZCARE MEDICAL CORP.; no. 3-1, minquan st.; tucheng dist; new taipei city, 23679 ; TW 23679
• MDR Report Key: 15001780
• Report Number: 2438477-2022-00067
• Device Sequence Number: 13849063
• Product Code: FNM
• UDI-Device Identifier: 00822383111605
• UDI-Public: 822383111605
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/12/2022
• Report Date (Section F): 07/13/2022

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?: No
• Device Model Number: 14030
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 07/15/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/13/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 07/13/2022