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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 Computer Operating System Problem (2898)
Patient Problem No Code Available (3191)
Event Date 11/01/2019
Event Type  Injury  
Manufacturer Narrative
A follow up report will be submitted upon completion of the investigation.
 
Event Description
A customer reported that the device disarmed without delivering a shock during a resuscitation attempt.This event will be submitted as a serious injury because another device was used to continue a resuscitation attempt.
 
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.The customer biomedical engineer evaluated the device.
 
Event Description
A customer reported that the device disarmed without delivering a shock during a resuscitation attempt.This event will be submitted as a serious injury because another device was used to continue a resuscitation attempt.The customer reported that the machine disarmed without initiating a shock approximately four to six times during a defibrillation attempt on a patient in ventricular tachycardia.Another device was brought in while cpr was in progress.The customer reported that the patient was alert and responsive after a shock was delivered.The customer biomedical engineer evaluated the device.No recent errors were found in the error log.The repair history showed no recent repairs subsequent to not delivering a shock.The device passed performance verification, visual inspection, functional, diagnostic, safety, and battery capacity tests.The customer biomedical engineer also performed multiple shocks into an analyzer while on battery power with pads and paddles.All shocks registered and were in acceptable ranges.The customer did not request an evaluation from a philips field service engineer (fse).Philips requested but did not receive additional information from the customer.Philips was not able to confirm the reported malfunction.Because the problem could not be recreated, the cause cannot be determined.The device remains in service at the customer site.The information gathered for this report does not indicate a systemic, design, or labeling problem.No further investigation or action is warranted.
 
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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 Key9582431
MDR Text Key174759116
Report Number1218950-2020-00253
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 user facility
Type of Report Initial,Followup
Report Date 01/07/2020
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 01/07/2020
Initial Date FDA Received01/13/2020
Supplement Dates Manufacturer Received01/07/2020
Supplement Dates FDA Received04/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age59 YR
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