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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 Mechanics Altered (2984)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.
 
Event Description
It was reported to philips that the device failed the operational check. No further failure analysis was provided by the customer. There was no reported patient involvement.
 
Manufacturer Narrative
The processor pca was received for failure analysis. The reported problem was verified during lab tests. The solder contact pins common to connector j16 had lifted off the solder lands due to cold solder and/or physical stressing of the solder joints during the use of the device. The available information is consistent with a malfunction of the capacitor, case interconnect cable assembly, and processor pca. The cause of the processor pca malfunction was solder contact pins common to connector j16 had lifted off the solder lands due to cold solder and/or physical stressing of the solder joints during the use of the device. The available information from this report does not support that this malfunction represents a systemic, design, or labeling problem. No further investigation or action is warranted.
 
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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
robert corning
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key6274075
MDR Text Key66284840
Report Number1218950-2017-00556
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K031187
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Paramedic
Type of Report Initial,Followup
Report Date 12/29/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/24/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM3536A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/14/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/29/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/10/2010
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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