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Adverse Event Report

AGILENT TECHNOLOGIES, INC. HEARTSTREAM XL DEFIBRILLATOR   back to search results
Model Number M4735A
Event Type  Malfunction  
Event Description

The customer reported that the unit failed the 100j test. The unit displayed a "no shock delivered" message.

 
Manufacturer Narrative

H. 6. The complaint is still under investigation.

 
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Brand NameHEARTSTREAM XL
Type of DeviceDEFIBRILLATOR
Baseline Brand NameHEARTSTREAM XL
Baseline Generic NameDEFIBRILLATOR
Baseline Catalogue NumberM4735A
Baseline Model NumberM4735A
Baseline Device FamilyHEARTSTREAM XL
Baseline Device 510(K) NumberK001725
Baseline Device PMA Number
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed10/17/2000
Manufacturer (Section F)
AGILENT TECHNOLOGIES, INC.
3000 minuteman road
andover MA 01810 1099
Manufacturer (Section D)
AGILENT TECHNOLOGIES, INC.
3000 minuteman road
andover MA 01810 1099
Manufacturer Contact
jean schubach
3000 minuteman road
andover , MA 01810-1099
(978) 659 -3956
Device Event Key387236
MDR Report Key398185
Event Key376273
Report Number1218950-2002-00085
Device Sequence Number1
Product CodeMKJ
Report Source Manufacturer
Source Type User facility,Company Representative
Reporter Occupation UNKNOWN
Type of Report Initial,Followup
Report Date 05/08/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/03/2002
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator UNKNOWN
Device MODEL NumberM4735A
Device Catalogue NumberM4735A
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received05/08/2002
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/01/2001
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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