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Adverse Event Report

ADAC LABORATOERIES ADAC GENESYS CAMERA-COUNTERWEIGHT   back to search results
Model Number 1357
Event Date 07/25/1996
Patient Outcome  Required Intervention; Disability
Event Description

Hypercalcemic, terminal lung pt in nuclear medicine dept on table for a lung scan. Pt's left arm across chest for lateral view while camera rotated on circular gantry. Due to weak, emaciated condition, pt's arm slipped off abdomen and watch became caught on the counterweight cover where encased cable enters the cover. As camera rotated, the cover pulled the watch causing the left forearm to bend and break. Emergency stop button pushed. Gantry was moved in opposite direction to release arm.

 
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Brand NameADAC GENESYS
Type of DeviceCAMERA-COUNTERWEIGHT
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
ADAC LABORATOERIES
north reg offcs
2048 washington st
hanover MA 02339
Manufacturer (Section D)
ADAC LABORATOERIES
north reg offcs
2048 washington st
hanover MA 02339
Device Event Key61623
MDR Report Key61256
Event Key57600
Report Number61256
Device Sequence Number1
Product CodeIYX
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 07/30/1996
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/31/1996
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL Number1357
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/30/1996
Distributor Facility Aware Date07/25/1996
Device Age36 mo
Event Location Hospital
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided

Patient TREATMENT DATA
Date Received: 07/31/1996 Patient Sequence Number: 1
#TreatmentTreatment Date
1,CONTINUOUS HEPARIN INFUSION IN PERIPHERAL IV.,
2,IN PERIPHERAL IV.,

Database last updated on December 31, 2008

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