FDA Adverse Event Death Summary report: N

MDE ESCORT

MDR report key: 399628 · Received June 11, 2002

Report

Report Number
2022870-2002-00002
Event Type
Death
Date Received
June 11, 2002
Date of Event
May 28, 2002
Report Date
June 11, 2002
Manufacturer
MEDICAL DATA ELECTRONICS
Product Code
DRT
Removal / Correction Number
NA
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
CO, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

A PT WENT INTO ASYSTOLE, WHILE CONNECTED TO A BEDSIDE MONITOR COMMUNICATING TO A CENTRAL STATION. NEITHER DEVICE ALARMED, BUT A BLINKING RED BAR APPEARED ON THE PT TILE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 MDE ESCORT PT MONITOR DRT MEDICAL DATA ELECTRONICS 20300 NA

Patients

Seq Age Sex Outcome Treatment
1 UNKNOWN Death