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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS HEALTHCARE PHILIPS HEARTSTART MRX
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PHILIPS HEALTHCARE PHILIPS HEARTSTART MRX Back to Search Results
Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Improper or Incorrect Procedure or Method (2017)
Patient Problem Chest Pain (1776)
Event Date 08/05/2016
Event Type  Other  
Event Description
The pt is a (b)(6) year old male with history of hypertension and hyperlipidemia.He was admitted for chest pain and pt was noted to have periods of bradycardia lasting a few seconds on the monitor.Multifunctional electrode pads were applied to the pt and connected to a biphasic monitor defibrillator pacemaker in anticipation of transcutaneous pacing.An rn performing a routine defibrillator check unintentionally delivered 150 joules to the pt as the pt's electrode pads remained connected to the defibrillator.The rn did not check the connection of the pads to the defibrillator prior to testing.The pt experienced transient chest pain and due to the shock that resolved quickly without intervention.Pt was kept in ed all night for observation.Transcutaneous pacing was never required during the hospital stay.
 
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Brand Name
PHILIPS HEARTSTART MRX
Type of Device
PHILIPS HEARTSTART MRX
Manufacturer (Section D)
PHILIPS HEALTHCARE
andover MA
MDR Report Key5867971
MDR Text Key52087542
Report NumberMW5063998
Device Sequence Number1
Product Code LDD
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 08/08/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/08/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age47 YR
Patient Weight121
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