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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEARTSTART MRX

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PHILIPS MEDICAL SYSTEMS HEARTSTART MRX Back to Search Results
Model Number M3535A
Device Problems No Display/Image (1183); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
It was reported to philips healthcare that the heartstart mrx froze and would not allow them to exit or select anything.
 
Manufacturer Narrative
Pr#: (b)(4).A follow-up report will be submitted upon completion of the investigation.
 
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Brand Name
HEARTSTART MRX
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman rd.
andover MA 01810
Manufacturer Contact
phyllis mccarthy
3000 minuteman rd.
andover, MA 01810
9786592811
MDR Report Key4081374
MDR Text Key15807600
Report Number1218950-2014-04029
Device Sequence Number1
Product Code MJK
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K031187
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 06/18/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM3535A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/18/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/01/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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