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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HEARTSTART MRX AIRWORTHY; DEFIBRILLATOR
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PHILIPS NORTH AMERICA LLC HEARTSTART MRX AIRWORTHY; DEFIBRILLATOR Back to Search Results
Model Number M3536M
Medical Device Problem Code Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 06/30/2021
Type of Reportable Event Malfunction
Event or Problem Description
It was reported to philips that the paddles do not work, not recognizing the pads.The customer worked with the technical support representative.The customer's update finds the issue resolved itself.The customer's update finds the issue resolved itself.The customer wishes to cancel the case.Philips cannot rule out a malfunction at the time it was reported, but no problem could be reproduced and no repair was warranted.There is no indication of a systemic problem; no further investigation or action is warranted.
 
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Brand Name
HEARTSTART MRX AIRWORTHY
Common Device Name
DEFIBRILLATOR
Manufacturer (Section D)
PHILIPS NORTH AMERICA LLC
22100 bothell everett highway
bothell WA 98021
MDR Report Key12257034
Report Number3030677-2021-13287
Device Sequence Number17118681
Product Code MKJ
UDI-Device Identifier00884838006676
UDI-Public00884838006676
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
PMA/510(K) Number
K031187
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberM3536M
Device Catalogue NumberM3536M
Was Device Available for Evaluation? Yes
Distributor Facility Aware Date06/30/2021
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/30/2021
Initial Report FDA Received Date07/31/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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