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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 Sparking (2595)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
A follow up report will be submitted upon completion of the investigation.
 
Event Description
It was reported to philips the external paddles produced an electric spark in using in (b)(6) 2019.It is unknown if the issue occurred during patient use, and no adverse event to patient or user was reported.Additional details have been requested.
 
Event Description
It was reported to philips the external paddles produced an electric spark in july 2019.It was clarified the issue occurred during testing.There was no patient involvement.
 
Manufacturer Narrative
Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
 
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Brand Name
HEARTSTART MRX
Type of Device
DEFIBRILLATOR
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
MDR Report Key10059904
MDR Text Key191306981
Report Number1218950-2020-02836
Device Sequence Number1
Product Code MKJ
UDI-Device Identifier00884838000018
UDI-Public(01)00884838000018
Combination Product (y/n)N
PMA/PMN Number
K031187
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Type of Report Initial,Followup
Report Date 04/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM3535A
Device Catalogue NumberM3535A
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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