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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS SMALL SWITCHED INT PDLS; PHILIPS HEARTSTART INT PDLS
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PHILIPS MEDICAL SYSTEMS SMALL SWITCHED INT PDLS; PHILIPS HEARTSTART INT PDLS Back to Search Results
Model Number M4744A
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Death (1802)
Event Type  malfunction  
Manufacturer Narrative
A follow up report will be submitted upon completion of the investigation.
 
Event Description
The customer reported that the internal paddles failed during use on a patient.The customer reported two internal paddle sets failed during this event where the involved patient died.The first paddle set failure and patient death is addressed in mdr 1218950-2015-05489, this case will be filed as a non adverse event to address the second paddle set failure.
 
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Brand Name
SMALL SWITCHED INT PDLS
Type of Device
PHILIPS HEARTSTART INT PDLS
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
denyse murphy
3000 minuteman road
andover, MA 01810
MDR Report Key5144125
MDR Text Key28401904
Report Number1218950-2015-05488
Device Sequence Number1
Product Code LDD
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K021453
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Other
Type of Report Followup
Report Date 10/07/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM4744A
Device Lot Number3-13
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received10/06/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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