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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEARTSTART MRX -EMS DEFIBRILLATOR

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PHILIPS MEDICAL SYSTEMS HEARTSTART MRX -EMS DEFIBRILLATOR Back to Search Results
Model Number M3536A
Device Problem Communication or Transmission Problem (2896)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
A follow-up report will be submitted once the investigation is completed.
 
Event Description
It was reported to philips that the device will not recognize the lead and the customer cannot complete the 12 lead. There was no reported patient or user involvement and no adverse patient/user impact.
 
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Brand NameHEARTSTART MRX -EMS DEFIBRILLATOR
Type of DeviceDEFIBRILLATOR
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
bethany glynn
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key8106413
MDR Text Key128564557
Report Number1218950-2018-09237
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
Report Date 11/01/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM3536A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/01/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/14/2010
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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