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Adverse Event Report

CABLETRON SYSTEMS MULTIPORT TRANSCEIVER   back to search results
Model Number MT-800
Event Date 03/24/1992
Patient Outcome  Other;
Event Description

On march 24, 1992, a cabletron multiport transceiver was found smoking in icu. This is used to interface all spacelabs monitors in icu. If this transceiver had failed completely, communication would have been lost between the bedside monitors and the central station and recorders. Failed unit was replaced with a new modle manufactured by allied telesis, model at-810. These units are used with spacelabs monitoring systems invalid data - regarding single use labeling of device. Patient medical status prior to event: invalid data. Invalid data - regarding multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. 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, visual examination. Results of evaluation: component failure, telemetry failure, component failure. Conclusion: device failure directly caused event. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device permanently removed from service, invalid data. Invalid data - on device destroyed/disposed of status.

 
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Brand NameMULTIPORT TRANSCEIVER
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
CABLETRON SYSTEMS
Manufacturer (Section D)
CABLETRON SYSTEMS
Device Event Key414
MDR Report Key420
Event Key357
Report Number420
Device Sequence Number1
Report Source User Facility
Reporter Occupation Unknown
Type of Report Initial
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/17/1992
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Other
Device MODEL NumberMT-800
Device LOT Number0058735
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Unknown
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/24/1992
Device Age01-may-91
Event Location Hospital
Date Report TO Manufacturer03/27/1992
Is the Device an Implant? No Answer Provided

Database last updated on January 30, 2009

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