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Adverse Event Report

ELGEMS, LTD. MILLENIUM VG NUCLEAR MEDICINE   back to search results
Model Number SYS000002
Event Date 10/21/2002
Event Type  Malfunction  
Event Description

Gems received a report of a collimator that started to fall from the cart, just prior to collimator exchange. The collimator came off the pins that were holding it, as the cart rolled over the floor plate between the detectors, in preparation for collimator exchange. Two local hospital technicians grasped the collimator, preventing it from falling further or hitting the detector. No injuries or other adverse events were reported.

 
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Brand NameMILLENIUM VG
Type of DeviceNUCLEAR MEDICINE
Baseline Brand NameMILLENIUM VG
Baseline Generic NameNUCLEAR MEDICINE
Baseline Catalogue NumberNA
Baseline Model NumberSYS000002
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
ELGEMS, LTD.
advanced technology center
haifa
ISRAEL 31004
Manufacturer (Section D)
ELGEMS, LTD.
advanced technology center
haifa
ISRAEL 31004
Manufacturer Contact
tracey fox
po box 414
milwaukee , WI 53201
(262) 513 -4061
Device Event Key427863
MDR Report Key438940
Event Key415411
Report Number9613299-2003-00001
Device Sequence Number1
Product CodeIYX
Report Source Manufacturer
Source Type User facility
Reporter Occupation UNKNOWN
Type of Report Initial
Report Date 01/15/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/16/2003
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberSYS000002
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA? No
Date Manufacturer Received10/22/2002
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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