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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 Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
The customer reported that the device is not recognizing the battery in bay b. There was no adverse patient impact reported.
 
Manufacturer Narrative
The power pca was returned for failure analysis. The reported problem could not be verified or duplicated during lab tests. No fault was found with this power pca. Philips cannot rule out a malfunction of the power pca at the time of the reported event.
 
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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
9723897516
MDR Report Key5984169
MDR Text Key56001134
Report Number1218950-2016-06120
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 09/06/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/28/2016
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 Manufacturer12/02/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/06/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/20/2014
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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