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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EEZCARE MEDICAL CORP. MED AIRE; BARIATRIC ALTERNATING PRESSURE AND LOW AIR LOSS MATTRESS SYSTEM
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EEZCARE MEDICAL CORP. MED AIRE; BARIATRIC ALTERNATING PRESSURE AND LOW AIR LOSS MATTRESS SYSTEM Back to Search Results
Model Number 14030
Device Problem Decreased Pump Speed (1500)
Patient Problem Ulcer (2274)
Event Date 06/11/2022
Event Type  Injury  
Event 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.
 
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Brand Name
MED AIRE
Type of Device
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 Key15001780
MDR Text Key295796144
Report Number2438477-2022-00067
Device Sequence Number1
Product Code FNM
UDI-Device Identifier00822383111605
UDI-Public822383111605
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 07/13/2022,07/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Model Number14030
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/13/2022
Date Report to Manufacturer07/15/2022
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient SexMale
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