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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 Problem Sparking (2595)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/23/2021
Event Type  malfunction  
Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.
 
Event Description
It was reported that the device's paddle holder was burned. There was reportedly 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
jacqueline nishino
22100 bothell everett highway
bothell, WA 98021
9095703538
MDR Report Key12169286
MDR Text Key261576402
Report Number3030677-2021-12974
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K031187
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/14/2021
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? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date06/23/2021
Event Location No Information
Date Manufacturer Received06/23/2021
Was Device Evaluated by Manufacturer? Yes
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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