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

Model Number 14030

Device Problem No Pressure (2994)

Patient Problem Pressure Sores (2326)

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 288666420
• Report Number: 2438477-2022-00022
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 00822383111605
• UDI-Public: 822383111605
• 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: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 14030
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/06/2022
• Distributor Facility Aware Date: 02/04/2022
• Event Location: Home
• Date Report to Manufacturer: 04/06/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Sex: Female