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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS CODEMASTER XL+; DEFIB/MONITOR

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PHILIPS MEDICAL SYSTEMS CODEMASTER XL+; DEFIB/MONITOR Back to Search Results
Model Number M1722A
Device Problems Device Operates Differently Than Expected (2913); No Pacing (3268)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Event Description
The customer contacted philips healthcare to report that no tcp (pacing)function when testing.There was no reported patient involvement.
 
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Brand Name
CODEMASTER XL+
Type of Device
DEFIB/MONITOR
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
denyse murphy
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key6376986
MDR Text Key69266577
Report Number1218950-2017-01498
Device Sequence Number1
Product Code LDD
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K954957
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 02/07/2017
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 NumberM1722A
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/07/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/15/1998
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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