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Adverse Event Report

ENRAF NONIUS ELECTROTHERAPY EQUIPMENT   back to search results
Model Number ENDOME 433
Event Date 11/19/1992
Patient Outcome  Other;
Event Description

Patient felt an uncomfortable electrical charge when machine was initially turned on, but before controls were set. Service technician from company, that the hospital purchased the equipment from, evaluated machine and found no malfunction. He recommedned for future use that the machine be turned on before applying electrodes to patient to release any static build-up. Machine is being sent to distributor for further evaluation device not labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-sep-92. Service provided by: user facility biomedical/bioengineering department. Service records available. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, electrical tests performed. Results of evaluation: other. Conclusion: other. Certainty of device as cause of or contributor to event: yes. Corrective actions: device temporarily removed from service, device use continued with restrictions/limitations, user education provided. Invalid data - on device destroyed/disposed of status.

 
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Type of DeviceELECTROTHERAPY EQUIPMENT
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
ENRAF NONIUS
Manufacturer (Section D)
ENRAF NONIUS
Device Event Key2480
MDR Report Key2654
Event Key2185
Report Number2654
Device Sequence Number1
Product CodeJXK
Report Source User Facility
Reporter Occupation Unknown
Type of Report Initial
Report Date 12/02/1992
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/11/1993
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Other Health Care Professional
Device MODEL NumberENDOME 433
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Unknown
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/02/1992
Distributor Facility Aware Date11/19/1992
Device Age01-sep-87
Event Location Hospital
Date Report TO Manufacturer11/20/1992
Is the Device an Implant? No

Database last updated on January 30, 2009

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