FDA Adverse Event Death Summary report: N

MULTINEX

MDR report key: 59195 · Received December 10, 1996

Report

Report Number
2221819-1996-00005
Event Type
Death
Date Received
December 10, 1996
Date of Event
August 18, 1996
Report Date
December 10, 1996
Manufacturer
DATASCOPE CORPORATION
Product Code
CCL
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
PA, US
Reporter Occupation
BIOMEDICAL ENGINEER

Narratives

Description of Event or Problem · 1

WHILE IN USE ON A PT THE UNIT DISPLAYED ERRONEOUS AGENT READINGS. THE PT LATER EXPIRED. THE CUSTOMER DOES NOT ATTRIBUTE THE DEATH OF THE DEATH TO THE UNIT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 MULTINEX GAS ANALYZER CCL DATASCOPE CORPORATION MULTINEX NA

Patients

Seq Age Sex Outcome Treatment
1 UNKNOWN