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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEARTSTART XL+ DEFIBRILLATOR/MONITOR; ALS DEFIBRILLATOR MONITOR
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PHILIPS MEDICAL SYSTEMS HEARTSTART XL+ DEFIBRILLATOR/MONITOR; ALS DEFIBRILLATOR MONITOR Back to Search Results
Model Number 861290
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Injury (2348)
Event Date 12/22/2020
Event Type  Injury  
Manufacturer Narrative
A follow up report will be submitted after philips obtains more information concerning this event.Patient details were requested but were unknown.
 
Event Description
It was reported to philips the switched internal paddle could not be used during open heart surgery.Another internal paddle 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 switched internal paddle could not be used during open heart surgery.Another internal paddle was used to treat the patient.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.No ecg monitoring strips or case event files were provided to philips for review.A philips field service engineer (fse) evaluated the device.The reported issue was confirmed and traced to a faulty internal paddle.The fse replaced the internal paddle.The defibrillator passed all performance assurance tests and was placed back into use with the customer.
 
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Brand Name
HEARTSTART XL+ DEFIBRILLATOR/MONITOR
Type of Device
ALS DEFIBRILLATOR MONITOR
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
MDR Report Key11104228
MDR Text Key224739839
Report Number1218950-2021-00001
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
PMA/PMN Number
K110825
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Type of Report Initial,Followup
Report Date 12/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number861290
Device Catalogue Number861290
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
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