MAUDE Adverse Event Report: EEZCARE MEDICAL CORP MED AIRE; BARIATRIC LOW AIR LOSS MATTRESS

Model Number	14030
Medical Device Problem Code	No Pressure (2994)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) healthcare was contacted on (b)(6) 2022 regarding a reported injury involving a bariatric low air loss mattress, which are intended to be used as one component of a comprehensive, multi-disciplinary pressure injury management program.The patient's occupational therapist reports that the patient, who is bed bound, received the mattress in (b)(6) 2021 and had problems with it from the beginning, but was unable to get the service provider to come look at it during the pandemic, and now the service provider will not return calls.The therapist reported that "the mattress will not alternate," and that the patient has developed 2 pressure sores due to the mattress not functioning properly.(b)(6) has yet to receive any information regarding the patient's overall pressure injury management program.(b)(6) is working to have the product returned for evaluation, and will continue to investigate the incident.

• Brand Name: MED AIRE
• Common Device Name: BARIATRIC LOW AIR LOSS MATTRESS
• Manufacturer (Section D): EEZCARE MEDICAL CORP; no. 3-1, minquan st.; tucheng dist.; new taipei city, tw 23679
• MDR Report Key: 14021572
• Report Number: 2438477-2022-00022
• Device Sequence Number: 19481888
• Product Code: FNM
• UDI-Device Identifier: 00822383111605
• UDI-Public: 822383111605
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/06/2022
• Report Date (Section F): 04/06/2022

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 14030
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/04/2022
• Event Location: Home
• Date Report to Manufacturer: 04/06/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/06/2022
• 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: Other; Required Intervention
• Patient Sex: Female
• Date Report Sent to FDA: 04/06/2022