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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS LARGE SWITCHLESS INTERNAL PADDLES; DEFIBRILLATOR
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PHILIPS MEDICAL SYSTEMS LARGE SWITCHLESS INTERNAL PADDLES; DEFIBRILLATOR Back to Search Results
Model Number M1742A
Device Problems Defibrillation/Stimulation Problem (1573); Low impedance (2285); Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
 
Event Description
It was reported to philips that the device failed to shock when using internal paddles, displaying a message regarding low impedance.There was no negative patient impact.
 
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Brand Name
LARGE SWITCHLESS INTERNAL PADDLES
Type of Device
DEFIBRILLATOR
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
betty harris
3000 minuteman road
andover, MA 01810
MDR Report Key5450878
MDR Text Key38695503
Report Number1218950-2016-01096
Device Sequence Number1
Product Code LDD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K030417
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 01/27/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM1742A
Device Lot Number09-2014
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/03/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/27/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/16/2011
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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