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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 Problems Failure to Deliver Shock/Stimulation (1133); Device Displays Incorrect Message (2591)
Patient Problem Injury (2348)
Event Date 11/14/2020
Event Type  Injury  
Manufacturer Narrative
A follow-up report will be submitted once the investigation is completed.
 
Event Description
It was reported to philips the heartstart mrx failed to shock a cardiac arrest patient.The monitor displayed an error message that stated shock not delivered.The monitor also advised to press down on the pads.A second attempt was made to shock the patient after adjusting the pads as per the direction of the monitor and again the monitor failed to shock the patient.Cpr continued and an attempt was made to shock the patient utilizing the heartstart fr3 aed.The fr3 advised shock not delivered.The pads were then changed and another attempt was made to shock the patient.The fr3 advised shock not delivered.Cpr continued the pads were changed and attached to the heartstart mrx once again.At this time the heartstart mrx monitor delivered a shock.Cpr was resumed.An organized rhythm with a carotid pulse was noted.The device was reported to be in use on a patient, causing a delay in life threatening therapy/treatment and will be considered a serious injury.However, no direct adverse event to the patient or user was reported.Note that the heartstart fr3 aed shock not delivered issue is addressed in (b)(4) (mfr.Report #:3030677-2020-02010).
 
Event Description
It was reported to philips the heartstart mrx failed to shock a cardiac arrest patient.The monitor displayed an error message that stated shock not delivered.The monitor also advised to press down on the pads.A second attempt was made to shock the patient after adjusting the pads as per the direction of the monitor and again the monitor failed to shock the patient.Cpr continued and an attempt was made to shock the patient utilizing the heartstart fr3 aed.The fr3 advised shock not delivered.The pads were then changed and another attempt was made to shock the patient.The fr3 advised shock not delivered.Cpr continued the pads were changed and attached to the heartstart mrx once again.At this time the heartstart mrx monitor delivered a shock.Cpr was resumed.An organized rhythm with a carotid pulse was noted.The device was reported to be in use on a patient, causing a delay in life saving therapy/treatment and will be considered a serious injury.However, no direct adverse event to the patient or user was reported.Note that the heartstart fr3 aed shock not delivered issue is addressed in (b)(4) (mfr.Report #:3030677-2020-02010).A philips clinician evaluated the patient event file.The device was powered on into the manual mode and pads were placed.There were six attempted shock deliveries between 17:06 elapsed time (et) and 21:03 et.Five of those shocks were aborted (not delivered), and one was manually disarmed.At 25:18 et a 200j shock was delivered and the rhythm was converted to an organized rhythm with a carotid pulse.The event file showed frequent ¿pads off¿ and ¿pads on¿ messages, consistent with insufficient pads to patient contact.The users reported having received a message to ¿press down on the pads¿.The heartstart mrx instructions for use (ifu - publication 453564307761 edition 2, page 316) advises the user how to troubleshoot when the ¿no shock delivered, press pads firmly¿ message is displayed due to poor pads contact with the patient (high impedance).The ifu advises the user to make sure pads are applied properly and to firmly press pads on the patient¿s chest.A philips field service engineer evaluated the defibrillator and was unable to duplicate the issue.The defibrillator passed all performance assurance testing.The device was placed into use with the customer.
 
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 -EMS DEFIBRILLATOR
Type of Device
DEFIBRILLATOR
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
MDR Report Key11085381
MDR Text Key224027040
Report Number1218950-2020-08119
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
PMA/PMN Number
K031187
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 12/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM3536A
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/07/2020
Initial Date FDA Received12/28/2020
Supplement Dates Manufacturer Received12/07/2020
Supplement Dates FDA Received02/18/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
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