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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HEARTSTART MRX MONITOR/DEFIB DEFIBRILLATOR

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PHILIPS NORTH AMERICA LLC HEARTSTART MRX MONITOR/DEFIB DEFIBRILLATOR Back to Search Results
Model Number M3535A
Device Problems Failure of Device to Self-Test (2937); Output below Specifications (3004)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/06/2021
Event Type  malfunction  
Event Description
It was reported to philips that the device had a low shock output and subsequently experienced a defib test failure. There was no patient involvement.
 
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Brand NameHEARTSTART MRX MONITOR/DEFIB
Type of DeviceDEFIBRILLATOR
Manufacturer (Section D)
PHILIPS NORTH AMERICA LLC
22100 bothell everett highway
bothell WA 98021
Manufacturer (Section G)
PHILIPS NORTH AMERICA LLC
22100 bothell everett highway
bothell WA 98021
Manufacturer Contact
elizabeth proctor
22100 bothell everett highway
bothell, WA 98021
9095703538
MDR Report Key12715715
MDR Text Key279027396
Report Number3030677-2021-15282
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K031187
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM3535A
Device Catalogue NumberM3535A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/12/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/19/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/16/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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