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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEARTSTART MRX; DEFIBRILLATOR
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PHILIPS MEDICAL SYSTEMS HEARTSTART MRX; DEFIBRILLATOR Back to Search Results
Model Number M3535A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Ventricular Tachycardia (2132)
Event Type  malfunction  
Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
 
Event Description
It was reported to philips that the device acoustical charge and optical shock indicators were absent during use treating a patient.The patient involved was reported to not have experienced harm or adverse patient impact.There was no report of any additional immediate clinical action taken to prevent serious injury or death.It was reported that the patient had ventricular tachycardia when the resuscitation team arrived.This event had hemodynamic relevance.The patient was shocked and immediately resuscitated.Afterwards, the patient was stable and was transferred to the intensive care unit.The indication was that there may have been a few seconds delay in the charging time.
 
Event Description
It was reported to philips that the device acoustical charge and optical shock indicators were absent during use treating a patient.The patient involved was reported to not have experienced harm or adverse patient impact.There was no report of any additional immediate clinical action taken to prevent serious injury or death.It was reported that the patient had ventricular tachycardia when the resuscitation team arrived.This event had hemodynamic relevance.The patient was shocked and immediately resuscitated.Afterwards, the patient was stable and was transferred to the intensive care unit.The indication was that there may have been a few seconds delay in the charging time.This will not be considered as a serious injury, but as a non-adverse event.This was delivery of critical therapy as intended to a patient needing critical therapy.
 
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Brand Name
HEARTSTART MRX
Type of Device
DEFIBRILLATOR
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
richa shah
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key7261312
MDR Text Key99920605
Report Number1218950-2018-01568
Device Sequence Number1
Product Code MKJ
UDI-Device Identifier00884838000018
UDI-Public(01)00884838000018
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K031187
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM3535A
Device Catalogue NumberM3535A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/25/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/16/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/27/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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