AIRLIFE¿
Received Oct 20, 2025 · Event occurred Jun 30, 2025
Report 23335307 · MDR key 23335307
Device
Generic name
Conserver, Oxygen
Manufacturer
Vyaire Medical, Inc.Model number
SFT2601Catalog number
SFT2601
Product problems
- Disconnection
Patient
12 DA · Male
- Low Oxygen Saturation
- Low Oxygen Saturation
Narrative
Description of Event or Problem
THERE WERE THREE REPORTS FROM DIFFERENT DATES ([REDACTED], [REDACTED], AND [REDACTED]) OF INSTANCES WHERE AN AIRLIFE NASAL CANNULA FELL OFF OF THE COMPATIBLE HUMIDIFIER CONNECTION. EVENT ON [REDACTED], PT: [REDACTED]: AIRLIFE INFANT CUSHION NASAL CANNULA MODEL #: 537838, SERIAL #: [REDACTED], LOT # UNKNOWN. "INFANT WAS DESATURATING AND RN FOUND THAT NASAL CANNULA HAD BECOME DISCONNECTED FROM THE HUMIDIFIER. NO ONE WAS IN THE ROOM WITH THE INFANT; IT HAD APPARENTLY FALLEN OFF OF CONNECTOR. RN RECONNECTED THE NASAL CANNULA TO THE HUMIDIFIER. THERE WERE NO CRACKS IN THE NASAL CANNULA TUBING." NO HARM TO THE PATIENT. EVENT [REDACTED], PT: [REDACTED]: AIRLIFE NASAL CANNULA AND OXYGEN TUBING MODEL #: SFT2601, SERIAL NUMBER: UNKNOWN, LOT #: UNKNOWN. "PATIENT'S NASAL CANNULA BECAME DISCONNECTED FROM THE HUMIDIFICATION CONNECTOR, AND THE PATIENT DESATURATED. PATIENT REQUIRED OXYGEN THERAPY TO BRING O2 [OXYGEN] SATS UP." NO HARM TO THE PATIENT. EVENT [REDACTED], PT: [[REDACTED]: AIRLIFE NASAL CANNULA MODEL #: UNKNOWN, SERIAL #: UNKNOWN, LOT # TL2602006. "WENT TO BEDSIDE FOR MIDNIGHT CARE TIME FOR INFANT. TRACED LINES WITH PRECEPTOR AND FOUND NASAL CANNULA DISCONNECTED FROM HUMIDITY AND ON THE GROUND. CONNECTION CLEANED AND REATTACHED TO HUMIDIFIER. NO INFANT DESATURATION NOTED. I NOTIFIED NICU [NEONATAL INTENSIVE CARE UNIT] PROVIDER." NO HARM TO THE PATIENT. NICU LEADERSHIP MEMBER, [REDACTED], CONTACTED THE REP [REPRESENTATIVE] AND HAD A MEETING WITH THEM ON [REDACTED] REGARDING THE NEW PRODUCT AND ISSUES THAT THE UNIT WAS HAVING. UNSURE OF RESOLUTION FROM MEETING.