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Adverse Event Report

AGILENT TECHNOLOGIES, INC. CODEMASTER 100 PORTABLE DEFIB/MON   back to search results
Model Number M2475B
Event Type  Malfunction  
Manufacturer Narrative

H. 4. Only the accessory ecg cable was examined. Because the customer did not provide the serial number of the defib/mon/rec, its mfr date could not be determined.

 
Event Description

The customer reported that during testing the accessory cable was found to be non functional - caused leads off errors.

 
Manufacturer Narrative

H. 1. Agilent technologies is still investigating this complaint and will send a follow-up report to the fda when the investigation is complete.

 
Search Alerts/Recalls

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Brand NameCODEMASTER 100
Type of DevicePORTABLE DEFIB/MON
Baseline Brand NameCODEMASTER 100
Baseline Generic NamePORTABLE DEFIB/MONITOR
Baseline Catalogue NumberM2475B
Baseline Model NumberM2475B
Baseline Device FamilyCODEMASTER 100 DEFIB/MONITOR
Baseline Device 510(K) NumberK954957
Baseline Device PMA Number
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed05/22/1995
Manufacturer (Section F)
AGILENT TECHNOLOGIES, INC.
3000 minuteman rd.
andover MA 01810 1099
Manufacturer (Section D)
AGILENT TECHNOLOGIES, INC.
3000 minuteman rd.
andover MA 01810 1099
Manufacturer Contact
deanna dunn
3000 minuteman road
andover , MA 01810-1099
(978) 659 -3065
Device Event Key299762
MDR Report Key309843
Event Key291210
Report Number1218950-2000-00278
Device Sequence Number1
Product CodeLDD
Report Source Manufacturer
Source Type Company Representative,User facility,Distributor
Reporter Occupation UNKNOWN
Type of Report Initial,Followup
Report Date 11/16/2000
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/19/2000
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator UNKNOWN
Device MODEL NumberM2475B
Device Catalogue NumberM2475B
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/21/2000
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/16/2000
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Reuse

Database last updated on February 28, 2009

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