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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 Failure to Deliver Shock/Stimulation (1133)
Patient Problems Death (1802); Sudden Cardiac Death (2510)
Event Date 04/05/2019
Event Type  Death  
Manufacturer Narrative
A follow up report will be submitted upon completion of the investigation.
 
Event Description
The customer reported that the device did not deliver the first of three shocks during attempt to resuscitate a patient in cardiac arrest while transporting the patient to the hospital.The device did not deliver a shock on the first attempt.The device delivered shocks on two subsequent attempts.The customer reported that the patient died after arrival at the hospital.
 
Event Description
The customer reported that the device did not deliver the first of three shocks during attempt to resuscitate a patient in cardiac arrest while transporting the patient to the hospital.The device did not deliver a shock on the first attempt.The device delivered shocks on two subsequent attempts.The customer reported that the patient died after arrival at the hospital.The device was sent to the philips bench for evaluation.The device passed all operations, systems and performance assurance tests.The device was returned to the customer.No case events files or ecg strips were provided to the customer for evaluation.Philips requested but did not receive additional information.Philips was not able to confirm the reported problem.Because the problem could not be recreated, the cause cannot be determined.The device remains in service at the customer site.The available information from this report does not support a systemic, design, or labeling problem.No further investigation or action is warranted.
 
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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
Manufacturer Contact
laura scanlan
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key8552735
MDR Text Key143205440
Report Number1218950-2019-03100
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 user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/05/2019
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? Device Returned to Manufacturer
Date Returned to Manufacturer05/24/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/05/2019
Initial Date FDA Received04/25/2019
Supplement Dates Manufacturer Received04/05/2019
Supplement Dates FDA Received11/22/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/20/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age58 YR
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