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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 Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problems Shaking/Tremors (2515); Shock from Patient Lead(s) (3162)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). 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 shocked a physician operating the device, causing the physician¿s hands to shake strongly. Philips is considering this event to be a serious injury because the operator of the device was shocked during use. Additional information has been requested.
 
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Brand NameHEARTSTART XL+ DEFIBRILLATOR/MONITOR
Type of DeviceALS DEFIBRILLATOR MONITOR
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
bethany glynn
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key9444089
MDR Text Key170042337
Report Number1218950-2019-09290
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeSI
PMA/PMN Number
K110825
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number861290
Device Catalogue Number861290
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/04/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/29/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 12/10/2019 Patient Sequence Number: 1
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