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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 Problems Failure of Device to Self-Test (2937); Mechanics Altered (2984)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported to philips that "the device is unable to load information during normal use" and the device kept cycling power during operations pre-check. There was no reported patient involvement/adverse patient impact.
 
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Brand NameHEARTSTART MRX
Type of DeviceDEFIBRILLATOR
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
betty harris
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key6392269
MDR Text Key69758196
Report Number1218950-2017-01582
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodePO
PMA/PMN Number
K031187
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation
Type of Report Initial
Report Date 02/21/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/09/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM3535A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/21/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/20/2015
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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