FDA Adverse Event Other Summary report: N

VAPOR PHASE PLUS HUMIDIFIER

MDR report key: 276892 · Received May 6, 2000

Report

Report Number
2020364-2000-00005
Event Type
Other
Date Received
May 6, 2000
Report Date
April 28, 2000
Manufacturer
SIMS/RESPIRATORY SUPPORT PRODUCTS, INC.
Product Code
BTT
Removal / Correction Number
NA
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
GA, US
Reporter Occupation
BIOMEDICAL ENGINEER

Narratives

Description of Event or Problem · 1

THE CONDITIONS OF USE ARE UNREPORTED. PT DATA IS UNREPORTED. THERE WAS NO INCIDENT REPORT FILED AND NO HARM TO THE PT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 VAPOR PHASE PLUS HUMIDIFIER VAPOR PHASE PLUS HUMIDIFIER BTT SIMS/RESPIRATORY SUPPORT PRODUCTS, INC. 009300 NA

Patients

Seq Age Sex Outcome Treatment
1 UNKNOWN