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Adverse Event Report

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

The customer reported that they are seeing "leads off" error messages.

 
Manufacturer Narrative

H. 4: the customer did not provide the device serial number, therefore, the device mfr date could not be determined. H. 6: the investigation found an open in the accessory 3 lead ecg cable.

 
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Brand NameCODEMASTER XL
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
sharon downs
3000 minuteman road
andover , MA 01810-1099
(978) 659 -3643
Device Event Key292957
MDR Report Key302675
Event Key284403
Report Number1218950-2000-00189
Device Sequence Number1
Product CodeLDD
Report Source Manufacturer
Source Type User facility,Company Representative
Reporter Occupation UNKNOWN
Type of Report Initial
Report Date 02/04/2000
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/27/2000
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 Manufacturer02/16/2000
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA? No
Date Manufacturer Received02/04/2000
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided
Type of Device Usage Reuse

Database last updated on February 28, 2009

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