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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS CODEMASTER 100; PORTABLE DEFIB/MONITOR

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PHILIPS MEDICAL SYSTEMS CODEMASTER 100; PORTABLE DEFIB/MONITOR Back to Search Results
Model Number M2475B
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Event Description
The customer reported that the device is not responding.There was no reported patient involvement.
 
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Brand Name
CODEMASTER 100
Type of Device
PORTABLE DEFIB/MONITOR
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
betty harris
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key6378461
MDR Text Key69331448
Report Number1218950-2017-01482
Device Sequence Number1
Product Code LDD
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K950483
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Other
Type of Report Initial
Report Date 02/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM2475B
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/14/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/29/1999
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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