MARQUETTE CD TELEMETRY CABINET UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-01-04 for MARQUETTE CD TELEMETRY CABINET UNKNOWN manufactured by Marquette Electronics, Inc..

Event Text Entries

[20682431] Patient found to have been discharged from central telemetry unit. This 76 year old indian female was admitted for cva, was s/p pacemaker insertion, being monitored on the telemetry unit. At approx. 2:28 p. M. A strip (ekg) was read on this patient. At approx. 6 pm-patient found to be unresponsive and had palpable pulse. On inspection of equipment - patient found to be discharged from the central telemetry unit & data on patient was irretreivable. Patient was appropriately connected. Four specific steps are necessary to discharge the patient. Staff is very familar with equipment & delay discharging pt. Manuallydevice not labeled for single use. Patient medical status prior to event: fair condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-sep-91. Service provided by: manufacturer. 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, computer software performance tests conducted, electrical tests performed, performance tests performed. Results of evaluation: none or unknown, telemetry equipment. Conclusion: device evaluated and alleged failure could not be duplicated, none or unknown. Certainty of device as cause of or contributor to event: invalid data. 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 Number2793
MDR Report Key2793
Date Received1993-01-04
Date of Report1991-12-11
Date of Event1991-11-29
Date Facility Aware1991-11-29
Report Date1991-12-11
Date Added to Maude1993-03-29
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 NamePATIENT TELEMETRY SYSTEM
Product CodeGYE
Date Received1993-01-04
Model NumberCD TELEMETRY CABINET
Catalog NumberUNKNOWN
ID NumberUNKNOWN
OperatorOTHER
Device AvailabilityY
Device Age01-SEP-89
Implant FlagN
Device Sequence No1
Device Event Key2619
ManufacturerMARQUETTE ELECTRONICS, INC.


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1993-01-04

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