MalfunctionCAN
OXYTOTE DTE
Received Mar 8, 2022 · Event occurred Jan 4, 2022
Report 1526809-2022-00001 · MDR key 13694056
Device
Generic name
Digital Oxygen Regulator
Manufacturer
Western/scott Fetzer Co.Model number
MNDR-600Catalog number
MNDR-600
Lot number
NONE
Product problems
- Device Emits Odor
Patient
Unknown
- Cough
- Cough
Narrative
Additional Manufacturer Narrative
INITIAL 30-DAY REPORT FILING WAS DELAYED DUE TO THE ENROLLMENT PROCESS.
Description of Event or Problem
AS HOSPITAL PERSONNEL ADMINISTERED OXYGEN TO THE PATIENT, THE PATIENT COMPLAINED OF AN ACRID SMELL WHICH PROMPTED THE PATIENT TO START COUGHING. THE UNIT WAS SHUT OFF AND REMOVED FROM THE ROOM. THE PATIENT'S COUGHING IMMEDIATELY SUBSIDED. NO INJURY OCCURRED, AND TREATMENT ASSOCIATED WITH THIS EVENT WAS NOT NECESSARY.