FDA Adverse Event Death Summary report: N

NELLCOR N-200

MDR report key: 320700 · Received March 15, 2001

Report

Report Number
2025525-2001-00001
Event Type
Death
Date Received
March 15, 2001
Date of Event
February 5, 2001
Report Date
March 14, 2001
Manufacturer
NELLCOR PURITAN BENNETT
Product Code
DQA
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
CA, US
Reporter Occupation
UNKNOWN

Narratives

Description of Event or Problem · 1

ON FEBRUARY, 2001, NELLCOR PURITAN BENNETT RECEIVED INFO THAT ALLEGED A PT HAD EXPIRED WHILE BEING MONITORED BY AN N-200 PULSE OXIMETER. ACCORDING TO THE FAMILY MEMBER, "FAMILY MEMBER DID NOT HEAR AN ALARM SOUNDING".

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
11657 NELLCOR N-200 PULSE OXIMETER DQA NELLCOR PURITAN BENNETT N-200 NA

Patients

Seq Age Sex Outcome Treatment
1 21 MO Death CPAP