FDA Adverse Event Other Summary report: N

HUMIDIFIER, RESPIRATORY GAS

MDR report key: 2950191 · Received January 16, 2013

Report

Report Number
2950191
Event Type
Other
Date Received
January 16, 2013
Date of Event
December 9, 2012
Report Date
January 16, 2013
Manufacturer
FISHER & PAYKEL HEALTHCARE LIMITED
Product Code
BTT
Product Problem
Yes
Report Source
User Facility report
Reporter Location
UT, US

Narratives

Description of Event or Problem · 1

RESPIRATORY THERAPY (RT) WAS CALLED TO BEDSIDE BY THE REGISTERED NURSE (RN) FOR PATIENT WITH INCREASED WORK OF BREATHING (WOB) WITH DESATURATION, NASAL FLARING, AND RETRACTIONS. THE PATIENT HAD A HIGH FLOW NASAL CANNULA (HFNC) WITH THE FISHER & PAYKEL SYSTEM. THE RN INCREASED THE FLOW AND FRACTION OF INSPIRED OXYGEN (FIO2) WITH THE PHYSICIAN AT THE BEDSIDE. WHEN RT ARRIVED, THE TEMPERATURE PROBE WAS FOUND DISCONNECTED FROM WHERE IT SHOULD NORMALLY CONNECT WITH THE HFNC AND THE PATIENT WAS NOT GETTING ANY FLOW OR FIO2 BECAUSE OF THIS LEAK IN THE CIRCUIT. THE PROBE WAS PLACED BACK IN AND RN/PHYSICIAN WERE NOTIFIED.THERE HAVE BEEN OTHER SIMILAR OCCURRENCES WITH THIS UNIT WHERE THE PROBE BECOMES DISLODGED.THE OTHER CONCERN THAT RT HAS IS THAT IF THE PROBE IS OUT FOR LONG ENOUGH, THE UNIT CONTINUES TO HEAT UP AND THEN WHEN THE PROBE IS REPLACED, IT COULD POTENTIALLY BLOW VERY HOT HUMIDIFIED AIR INTO THE AIRWAY.======================MANUFACTURER RESPONSE FOR INFANT CONTINUOUS FLOW CIRCUIT, (BRAND NOT PROVIDED) (PER SITE REPORTER).======================WE TALKED WITH THE LOCAL REPS FOR FISHER & PAYKEL (F&P). WE HAVE ALSO BEEN IN CONTACT WITH AND ENGINEER VIA EMAIL CONCERNING THE TEMPERATURE PROBE FIT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?O2 DELIVERY VIA HFNC.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
25268 HUMIDIFIER, RESPIRATORY GAS BTT FISHER & PAYKEL HEALTHCARE LIMITED RT329 *

Patients

Seq Age Sex Outcome Treatment
1 10 MO