FDA Adverse Event Death Summary report: N

ECG MONITORING SYSTEM

MDR report key: 13260 · Received February 9, 1994

Report

Report Number
13260
Event Type
Death
Date Received
February 9, 1994
Date of Event
December 28, 1993
Report Date
January 28, 1994
Manufacturer
MARQUETTE ELECTRONIC, INC.
Product Code
DPS
Adverse Event
Yes
Report Source
User Facility report
Reporter Location
OH, US
Reporter Occupation
INVALID DATA

Narratives

Description of Event or Problem · 1

PT WENT INTO VENTRICULAR FIBRILLATION AND ALTHOUGH ALARM FUNCTIONED, IT WAS NOT APPRECIATED BY STAFF SINCE THERE IS NO AUDIBLE ALARM ABLE TO BE FORWARDED AND THE VISUAL ALARM WAS NOT SUFFICIENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 ECG MONITORING SYSTEM ECG MONITORING SYSTEM DPS MARQUETTE ELECTRONIC, INC.

Patients

Seq Age Sex Outcome Treatment
1 * Death