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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 Device Inoperable (1663)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Event Description
It was reported to philips that the device's power indicator light is not functioning. The device was not in use on a patient.
 
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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 (Section G)
PHILIPS HEALTHCARE - BOTHELL
22100 bothell-everett hwy
bldg a
bothell WA 98021
Manufacturer Contact
stohn nishino
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key7655651
MDR Text Key113179914
Report Number1218950-2018-05372
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K031187
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial
Report Date 06/02/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/02/2018
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?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/02/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/13/2006
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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