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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 Poor Quality Image (1408)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported to philips that the device's front bezel is not clear. There was no patient involvement.
 
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Brand NameHEART START XL
Type of DeviceDEFIBRILLATOR
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
daniel derochers
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key10968373
MDR Text Key220243740
Report Number1218950-2020-07561
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K001725
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation
Type of Report Initial
Report Date 12/03/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM4735A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/03/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/07/2007
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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