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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
The device was evaluated by a philips bench repair technician who was unable to reproduce complaint issues. The philips bench repair technician replaced processor pca and internal memory due to a separate issue that has minimal health risk(empty logs in data management). ; (b)(4).
 
Event Description
The customer contact philips healthcare to report that the leads are not reading, it was reported that the alleged failure was observed while in use on a patient. No adverse patient impact was reported to philips.
 
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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
denyse murphy
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key6094251
MDR Text Key59943984
Report Number1218950-2016-07140
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
Type of Report Initial
Report Date 10/17/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/10/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM3536A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/09/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/17/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/25/2015
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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