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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 Communication or Transmission Problem (2896)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
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 was not recognizing the internal paddles. There was no patient involvement.
 
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Brand NameHEARTSTART XL+ DEFIBRILLATOR/MONITOR
Type of DeviceALS DEFIBRILLATOR MONITOR
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
22100 bothell everett hwy
bothell WA 98021
Manufacturer (Section G)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
daniel derochers
22100 bothell everett hwy
bothell, WA 98021
MDR Report Key11328041
MDR Text Key233118512
Report Number3030677-2021-00458
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeJA
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 01/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/15/2021
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? Device Returned to Manufacturer
Date Returned to Manufacturer03/08/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/27/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/12/2014
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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