MAUDE Adverse Event Report: EEZCARE MEDICAL CORP DRIVE; LOW AIR LOSS MATTRESS

Model Number	14027
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Ulcer (2274)
Date of Event	05/28/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was contacted regarding a reported injury involving a alternating pressure mattress low air loss system, which is intended to be used as one component of a comprehensive, multi-disciplinary pressure injury management program.The end user reported having developed a pressure wound on her bottom prior to commencing use of the device.After approximately eight months of using the device, her caretakers began to notice the development of additional pressure wounds, and she was taken to the hospital.Drive did not receive any information regarding the patient's overall pressure injury management program.Drive provided a replacement model to the end user, and is currently investigating the incident, including attempting to retrieve the product to evaluate it.

• Brand Name: DRIVE
• Common Device Name: LOW AIR LOSS MATTRESS
• Manufacturer (Section D): EEZCARE MEDICAL CORP; no 3-1 minquan st.; tucheng district, new taipei city 23679 ; CH 23679
• MDR Report Key: 14978480
• Report Number: 2438477-2022-00046
• Device Sequence Number: 20256502
• Product Code: FNM
• UDI-Device Identifier: 00822383221618
• UDI-Public: 822383221618
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 07/11/2022
• Report Date (Section F): 07/11/2022

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
• Operator of Device: Lay User/Patient
• Device Model Number: 14027
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/26/2021
• Device Age: 13 MO
• Event Location: Home
• Date Report to Manufacturer: 05/31/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/11/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Female
• Date Report Sent to FDA: 07/11/2022