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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 Communication or Transmission Problem (2896)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The customer requested just a replacement external paddle set with no engineer evaluation.
 
Event Description
It was reported to philips that the device does not recognize the external paddles.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 Name
HEARTSTART XL+ DEFIBRILLATOR/MONITOR
Type of Device
XL+ DEFIBRILLATOR
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 Key8409494
MDR Text Key138526215
Report Number1218950-2019-01934
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K110825
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Other
Type of Report Initial
Report Date 02/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/11/2019
Is this an Adverse Event Report? No
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
Date Manufacturer Received02/15/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/19/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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