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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 Patient-Device Incompatibility (2682)
Patient Problem Skin Irritation (2076)
Event Type  malfunction  
Event Description
A customer reported skin irritation after defibrillator pads were used on a patient.The device was reported to be in use on a patient, but there was no adverse event.
 
Event Description
A customer reported skin irritation after defibrillator pads were used on a patient.The device was reported to be in use on a patient, but there was no adverse event.The customer reported no red skin or blisters on the patient after the procedure.No treatment for burns was required.
 
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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
laura scanlan
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key8813193
MDR Text Key151848095
Report Number1218950-2019-05347
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K001725
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2019
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? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/01/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/02/2010
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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