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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 Failure to Deliver Energy (1211)
Patient Problem No Code Available (3191)
Event Date 10/01/2019
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 failed in energy delivery.On the philips customer feedback form, the reporter documented an adverse event had occurred on a patient.Additional information has been requested.
 
Event Description
It was reported to philips that the heartstart xl monitor / defibrillator failed in energy delivery.On the philips customer feedback form, the reporter documented an adverse event had occurred on a patient.The customer requested that a philips field service engineer (fse) be dispatched to the customer site.The reported issue was unable to be duplicated.The device was used on a simulator and worked as designed.No ecg monitoring strips or case event files were provided to philips for review.No parts were replaced.The device passed all performance assurance tests and was placed back into use with the customer.Philips was not able to confirm the reported malfunction.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
HEART START XL
Type of Device
DEFIBRILLATOR
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
MDR Report Key9162380
MDR Text Key162603544
Report Number1218950-2019-07631
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 10/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/07/2019
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 Received10/01/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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