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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS, INC. AMARA VIEW MASK; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

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RESPIRONICS, INC. AMARA VIEW MASK; VENTILATOR, NON-CONTINUOUS (RESPIRATOR) Back to Search Results
Model Number 1090602
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Partial Hearing Loss (4472)
Event Date 11/14/2022
Event Type  Injury  
Event Description
The manufacturer received information alleging an end user with ear implants experienced hearing loss while using the amara view face mask with magnetic clips.The user allegedly used the mask for two years and noticed a decline in his hearing.The care facility for patient care has changed the mask to one without magnets.No product will be returned for investigation.The manufacturer will continue to monitor complaints for similar issues.The manufacturer concludes no further action is needed at this time.
 
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Brand Name
AMARA VIEW MASK
Type of Device
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
Manufacturer (Section D)
RESPIRONICS, INC.
1001 murry ridge lane
murrysville PA 15668
Manufacturer (Section G)
RESPIRONICS, INC.
1001 murry ridge lane
murrysville PA 15668
Manufacturer Contact
kimberly shelly
6501 living place
pittsburgh, PA 15206
2673970028
MDR Report Key15835518
MDR Text Key304032920
Report Number2518422-2022-94792
Device Sequence Number1
Product Code BZD
UDI-Device Identifier00606959009134
UDI-Public00606959009134
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K082866
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/21/2022
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
Device Operator Lay User/Patient
Device Model Number1090602
Device Catalogue Number1090602
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/14/2022
Initial Date FDA Received11/21/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
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