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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEARTSTART MRX DEFIBRILLATOR

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PHILIPS MEDICAL SYSTEMS HEARTSTART MRX DEFIBRILLATOR Back to Search Results
Model Number M3535A
Device Problem Poor Quality Image (1408)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
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 has lines that appear when the device powers on, then the lines disappear. There was no patient involvement.
 
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Brand NameHEARTSTART MRX
Type of DeviceDEFIBRILLATOR
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
daniel derochers
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key10895227
MDR Text Key218641924
Report Number1218950-2020-07155
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 Biomedical Engineer
Type of Report Initial,Followup
Report Date 11/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM3535A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/10/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/20/2010
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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