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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEART START XL; DEFIBRILLATOR
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PHILIPS MEDICAL SYSTEMS HEART START XL; DEFIBRILLATOR Back to Search Results
Model Number M4735A
Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problem Shock from Patient Lead(s) (3162)
Event Date 12/20/2019
Event Type  Injury  
Manufacturer Narrative
A follow up report will be submitted upon completion of the investigation.
 
Event Description
It was reported to philips that the heartstart xl monitor / defibrillator unintentionally shocked a patient when no users were touching the device.Philips is considering this event to be a serious injury because the patient was unintentionally shocked (treatment administration error).It is unknown if the patient experienced an adverse event, and the outcome of the event is unknown.
 
Event Description
It was reported to philips that the heartstart xl monitor / defibrillator unintentionally shocked a patient when no users were touching the device.Philips is considering this event to be a serious injury because the patient was unintentionally shocked.The issue occurred while the user was monitoring the patient and no adverse event to patient or user was reported.The customer was unable to provide information regarding if the patient required any treatment.No ecg monitoring strips or case event files were provided to philips for review.A philips product support engineer evaluated the logs which were provided by the customer, however, the logs did not show evidence to explain the allegation.The customer declined evaluation of the device from philips.No conclusion can be drawn.The customer scrapped the device due to lack of replacement parts.No conclusion can be drawn.According to service bulletin sb86100166d, the m4735a heart/start xl portable defibrillator/monitor was discontinued on 31-december -2013.All options associated with this defibrillator were discontinued as of 31-december-2013.The end of support date for the device is 31-december -2018.The customer was aware of the end of life terms.
 
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
HEART START XL
Type of Device
DEFIBRILLATOR
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
MDR Report Key9521434
MDR Text Key172763329
Report Number1218950-2019-09794
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
PMA/PMN Number
K001725
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Type of Report Initial,Followup
Report Date 12/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM4735A
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/20/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
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