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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 Failure to Deliver Shock/Stimulation (1133)
Patient Problem No Code Available (3191)
Event Date 05/19/2020
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, during an intervention, the device was unable to shock with internal paddles.Another set of internal paddles needed to be used to treat the patient.The device was reported to be in use on a patient, causing a delay in life-threatening therapy/treatment requiring another device to continue treatment and will be considered a serious injury.However, no direct adverse event to the patient or user was reported.Additional details have been requested.
 
Event Description
It was reported to philips that, during an intervention, the device was unable to shock with internal paddles.Another set of internal paddles needed to be used to treat the patient.The device was reported to be in use on a patient, causing a delay in life-threatening therapy/treatment requiring another device to continue treatment and will be considered a serious injury.However, no direct adverse event to the patient or user was reported.The customer stated the device did not cause or contribute to the event because they had another set of internal paddles.There were no ecg monitoring strips or patient event files available to send to us for review.A non-philips dealer field service engineer evaluated the device and was unable to duplicate the issue.No parts were replaced.The device passed all performance assurance tests and was placed back into use with the customer.The reported malfunction could not be confirmed.Because the problem could not be recreated, the cause cannot be determined.
 
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
HEARTSTART XL+ DEFIBRILLATOR/MONITOR
Type of Device
ALS DEFIBRILLATOR MONITOR
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
MDR Report Key10088151
MDR Text Key192039132
Report Number1218950-2020-03075
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 05/19/2020
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 Number861290
Device Catalogue Number861290
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/19/2020
Initial Date FDA Received05/26/2020
Supplement Dates Manufacturer Received05/19/2020
Supplement Dates FDA Received06/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
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