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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 Power Problem (3010)
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 ac module failed. 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
jacqueline nishino
22100 bothell everett highway
bothell, WA 98021
9095703538
MDR Report Key12715811
MDR Text Key279026420
Report Number3030677-2021-15285
Device Sequence Number1
Product Code MKJ
UDI-Device Identifier00884838000018
UDI-Public00884838000018
Combination Product (y/n)N
Reporter Country CodeIT
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
Remedial Action Replace
Type of Report Initial
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? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/06/2021
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
Removal/Correction NumberZ-1923-2019

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