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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 Therapeutic or Diagnostic Output Failure (3023)
Patient Problem No Code Available (3191)
Event Date 06/30/2020
Event Type  Injury  
Event Description
It was reported to philips the customer powered on the device which was needed to treat a patient in ventricular fibrillation.The device was programmed to 150j and, at the time of discharge, emitted a small burst sound similar to the fuse of a lamp and the device failed.Another device was used to treat the patient.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.
 
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.
 
Event Description
It was reported to philips the customer powered on the device which was needed to treat a patient in ventricular fibrillation.The device was programmed to 150j and, at the time of discharge, emitted a small burst sound similar to the fuse of a lamp and the device failed.Another device was used to treat the patient.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.A philips field service engineer (fse) evaluated the device and confirmed the reported issue.The fse found the power supply was broken and a screw was loose inside the device which caused a short circuit in the power pca board and power supply.No ecg monitoring strips or case event files were provided to philips for review.The fse is unable to replace faulty parts.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 and the device remains at the customer site.
 
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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 Key10240970
MDR Text Key197816259
Report Number1218950-2020-03913
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 06/29/2020
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 NumberM4735A
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/29/2020
Initial Date FDA Received07/07/2020
Supplement Dates Manufacturer Received06/29/2020
Supplement Dates FDA Received12/21/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
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