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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 Communication or Transmission Problem (2896)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Event Description
The customer reported that the device does not detect the parameters correctly. There was no reported 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
richa shah
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key6089275
MDR Text Key59888275
Report Number1218950-2016-07068
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeMX
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 10/14/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/09/2016
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 Received10/14/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/24/2010
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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