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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEARTSTART XL+ DEFIBRILLATOR/MONITOR XL+ DEFIBRILLATOR

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PHILIPS MEDICAL SYSTEMS HEARTSTART XL+ DEFIBRILLATOR/MONITOR XL+ DEFIBRILLATOR Back to Search Results
Model Number 861290
Device Problem Poor Quality Image (1408)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
A follow-up report will be submitted once the investigation is completed.
 
Event Description
It was reported to philips that the device image was not clear. There was no patient involvement. The efficia dfm100 defibrillator, model# 866199, is substantially similar to the heartstart xl+ defibrillator (model # 861290) and will be reported in the united states under device model # 861290.
 
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Brand NameHEARTSTART XL+ DEFIBRILLATOR/MONITOR
Type of DeviceXL+ DEFIBRILLATOR
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer (Section G)
PHILIPS MEDICAL SYSTEMS
22100 bothell everett hwy
bothell WA 98021
Manufacturer Contact
jacqueline nishino
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key9577802
MDR Text Key178779535
Report Number1218950-2020-00232
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeCH
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 12/24/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/10/2020
Is this an Adverse Event Report? No
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 Received12/24/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/17/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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