MARQUETTE 7700

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-05-12 for MARQUETTE 7700 manufactured by Marquette Medical Electronics, Inc..

Event Text Entries

[21381209] While being monitored on the telemetry step down unit, a patient suffered a ventricular arrhythmia. Nurses seated at the monitoring system stated that at the onset of the arrhythmia, the monitoring system failed to alarm or cause a graph to be generated. The graph was manually activated and a medical express team called immediately. The patient died subsequent to the express team resuscitation efforts. The telemetry unit, reciever and monitor involved was evaluated by the biomedical engineering division and no defect was founddevice not labeled for single use. Patient medical status prior to event: critical condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-mar-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, performance tests performed, visual examination. Results of evaluation: none or unknown. Conclusion: device evaluated and alleged failure could not be duplicated, no failure detected and product within specification. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: user education provided, inserviced by other facility staff. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 583
• MDR Report Key: 583
• Date Received: 1992-05-12
• Date of Report: 1992-04-28
• Date of Event: 1992-04-15
• Date Facility Aware: 1992-04-24
• Report Date: 1992-04-28
• Date Reported to Mfgr: 1992-04-28
• Date Added to Maude: 1992-05-19
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MARQUETTE
• Generic Name: TELEMETRY ECG SYSTEM
• Product Code: GYE
• Date Received: 1992-05-12
• Model Number: 7700
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Device Age: 01-FEB-91
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 574
• Manufacturer: MARQUETTE MEDICAL ELECTRONICS, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	1992-05-12