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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 Poor Quality Image (1408)
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 there was no information on the lcd. 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 Key6200165
MDR Text Key63509459
Report Number1218950-2016-08109
Device Sequence Number1
Product Code MKJ
UDI-Device Identifier00884838006652
UDI-Public(01)00884838006652
Combination Product (y/n)N
Reporter Country CodeJA
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,Followup
Report Date 10/21/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/22/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM3536A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/06/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/13/2016
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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