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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC AMARA VIEW MASK; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
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PHILIPS NORTH AMERICA LLC AMARA VIEW MASK; VENTILATOR, NON-CONTINUOUS (RESPIRATOR) Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/25/2022
Event Type  malfunction  
Event Description
The manufacturer received information alleging an end user had issues with his pacemaker while using the amara view full face mask.There was no report of serious patient harm or injury.There was no report of medical intervention.No further information is available at this time.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.
 
Manufacturer Narrative
Not returned to manufacturer.
 
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Brand Name
AMARA VIEW MASK
Type of Device
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
Manufacturer (Section D)
PHILIPS NORTH AMERICA LLC
1001 murry ridge lane
ste a
murrysville PA 15668
Manufacturer (Section G)
PHILIPS NORTH AMERICA LLC
1001 murry ridge lane
ste a
murrysville PA 15668
Manufacturer Contact
kimberly shelly
6501 living place
pittsburgh, PA 15208
4125423300
MDR Report Key15893640
MDR Text Key304985050
Report Number2518422-2022-100771
Device Sequence Number1
Product Code BZD
Combination Product (y/n)N
Reporter Country CodeGM
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
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/25/2022
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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