MARQUETTE 9484-200

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-11-20 for MARQUETTE 9484-200 manufactured by Marquette Electronics.

Event Text Entries

[1141] The activation of the generator and manual operation of the transfer switches once the generator is operational is performed on a monthly basis to test emergency generators. The normal building power remains "on" and only a momentary fluctuation occurs at the moment of transfer of the emergency power circuits to the generator. The specifications of the telementry equipment state sthey must operate without failure through a atransfer of power; and they have previously done so without complication. On one patient care unit, the central telemetry computer receivers locked up when the power was transferred. Other telemetry patient care units were unaffected. To "unlock" the unit telemetry, a biomedical instrumentation technician had to turn off, then back on, each individual telemetry computer receiver on the unit and then the unit system became operational. The actual equipment failure was in the monitoring branch exchange and the receivers in the telemetry system. Shortly after the equipment failed, a patient suffered cardiac arrest and diedinvalid data - regarding single use labeling of device. Patient medical status prior to event: critical condition. There was multiple patient involvement. Number of patients involved:. Device serviced in accordance with service schedule. Date last serviced: 01-oct-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, visual examination, other. Results of evaluation: electrical problem, telemetry failure, telemetry equipment. Conclusion: device failure indirectly contributed to event. Certainty of device as cause of or contributor to event: maybe. Corrective actions: device repaired and put back in service. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1813
MDR Report Key1813
Date Received1992-11-20
Date of Report1992-11-02
Date of Event1992-10-20
Date Facility Aware1992-10-20
Report Date1992-11-02
Date Reported to FDA1992-11-02
Date Reported to Mfgr1992-11-02
Date Added to Maude1992-12-04
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameMARQUETTE
Generic NameECG TELEMETRY
Product CodeGYE
Date Received1992-11-20
Model Number9484-200
ID Number44559
OperatorOTHER
Device AvailabilityY
Implant Flag*
Device Sequence No1
Device Event Key1691
ManufacturerMARQUETTE ELECTRONICS


Patients

Patient NumberTreatmentOutcomeDate
101. Death 1992-11-20

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