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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEART START XL; DEFIBRILLATOR
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PHILIPS MEDICAL SYSTEMS HEART START XL; DEFIBRILLATOR Back to Search Results
Model Number M4735A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Skin Discoloration (2074)
Event Type  malfunction  
Manufacturer Narrative
A follow-up report will be submitted once the investigation is completed.
 
Event Description
The customer reported seeing a burnt mark on patient when using switchless paddles there was no reported adverse patient harm.
 
Manufacturer Narrative
The device was evaluated by a philips field service engineer.The reported problem could not be confirmed.The device passed all performance assurance testing and no trouble was found.The device passed all performance assurance testing and was returned to clinical use.
 
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Brand Name
HEART START XL
Type of Device
DEFIBRILLATOR
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
nancy ataide
3000 minuteman road
andover, MA 01810
MDR Report Key5842736
MDR Text Key51025024
Report Number1218950-2016-04662
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeSN
PMA/PMN Number
K001725
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/28/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/03/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM4735A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/01/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/20/2002
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Congenital Anomaly;
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