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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PADS ¿ADULT RADIOLUCENT DEFIBRILLATOR

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PHILIPS MEDICAL SYSTEMS PADS ¿ADULT RADIOLUCENT DEFIBRILLATOR Back to Search Results
Model Number M3716A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Burn, Thermal (2530)
Event Type  malfunction  
Manufacturer Narrative
A follow up report will be submitted upon completion of the investigation.
 
Event Description
A customer reported that a patient was "burned" from use of the defibrillator pad. The device was reported to be in use on a patient; additional details regarding patient outcome have been requested.
 
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Brand NamePADS ¿ADULT RADIOLUCENT
Type of DeviceDEFIBRILLATOR
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 Key8640654
MDR Text Key146216459
Report Number1218950-2019-03771
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
K992543
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 05/03/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM3716A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/03/2019
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

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