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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS HEALTHCARE PHILIPS MRX CARDIAC MONITOR / DEFIBRILLATOR

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PHILIPS HEALTHCARE PHILIPS MRX CARDIAC MONITOR / DEFIBRILLATOR Back to Search Results
Model Number M3536A
Device Problem Failure to Capture (1081)
Patient Problems Bradycardia (1751); Bradycardia (1751); Death (1802); Tachycardia (2095); Tachycardia (2095); Loss of consciousness (2418); Loss of consciousness (2418); Lethargy (2560); Lethargy (2560)
Event Date 05/21/2018
Event Type  Death  
Event Description
Monitor failed to recognize pads and pace, amplitude would not increase to allow capture. Pt upon arrival was aax1, lethargic. Pt carried to unit, found to have a tachycardic rhythm. After approx 2 mins, pt became unresponsive, heart rhythm changed to bradycardia. Pacer pads put on pt, monitor stated to connect pads and pads cable. When monitor switched to pacer mode, amplitude selection would not change from 10ma. Capture was not possible.
 
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Brand NamePHILIPS MRX
Type of DeviceCARDIAC MONITOR / DEFIBRILLATOR
Manufacturer (Section D)
PHILIPS HEALTHCARE
andover MA
MDR Report Key8536657
MDR Text Key241261925
Report Number8536657
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/11/2019
1 Device was Involved in the Event
2 Patients were Involved in the Event: 1   2  
Date FDA Received04/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM3536A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA? No
Distributor Facility Aware Date05/25/2018
Device Age12 YR
Event Location Home
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/12/2019 Patient Sequence Number: 0
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