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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 Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
A follow-up report will be submitted once the investigation is complete.
 
Event Description
The customer reported that the device does not recognize battery a. There was no adverse patient impact reported.
 
Manufacturer Narrative
The customer declined repair by philips. The device has been returned to the customer site unrepaired.
 
Event Description
The customer reported that the device does not recognize battery. There was no reported patient involvement.
 
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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
wendy chadbourne
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key6056734
MDR Text Key58463208
Report Number1218950-2016-06735
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,Followup
Report Date 09/30/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/26/2016
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 Manufacturer10/11/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/30/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/24/2005
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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