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Adverse Event Report

ELGEMS, LTD. APEX SP-4 NUCLEAR SYSTEM NUCLEAR MEDICINE   back to search results
Model Number SP-4
Event Date 03/11/1999
Event Type  Malfunction  
Event Description

It was reported to gems that the operator failed to tighten the plate to the detector when replacing the collimator. The collimator and plate fell off when the detector was rotated over the pt. It touched the pt, but there was no injury.

 
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Brand NameAPEX SP-4 NUCLEAR SYSTEM
Type of DeviceNUCLEAR MEDICINE
Baseline Brand NameAPEX SP-4 NUCLEAR SYSTEM
Baseline Generic NameNUCLEAR MEDICINE
Baseline Catalogue NumberNA
Baseline Model NumberSP-4
Other Baseline ID Number416445SP4
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
ELGEMS, LTD.
advanced technology ctr
haifa
ISRAEL 31004
Manufacturer (Section D)
ELGEMS, LTD.
advanced technology ctr
haifa
ISRAEL 31004
Manufacturer (Section G)
GE MEDICAL SYSTEMS F.I. HAIFA
4 hayozma st.
tirat hacarmel
ISRAEL 30200
Device Event Key214470
MDR Report Key221165
Event Key207516
Report Number9613299-1999-00002
Device Sequence Number1
Product CodeIYY
Report Source Manufacturer
Source Type Other
Reporter Occupation UNKNOWN
Type of Report Initial
Report Date 04/22/1999
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/23/1999
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberSP-4
OTHER Device ID Number416445SP4
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Unknown
Was the Report Sent to FDA? No
Date Manufacturer Received03/11/1999
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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