FDA Adverse Event Malfunction Summary report: N

FL9000U RESPIRATORY HUMIDIFIER HEATER 100-120V WITH NEMA 5 - 15P 3 PIN PLUG

MDR report key: 14860634 · Received June 29, 2022

Report

Report Number: 3006061749-2022-00012
Event Type: Malfunction
Date Received: June 29, 2022
Date of Event: May 18, 2022
Report Date: June 29, 2022
Manufacturer: FLEXICARE MEDICAL LTD
Product Code: BTT
Removal / Correction Number: 1402800000-2022-8001
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IL, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

FLEXICARE HAS MADE MANY ATTEMPTS TO CONTACT THE FACILITY TO GAIN MORE INFORMATION REGARDING THE EVENT, NO INFORMATION HAS BEEN GIVEN AND THE DEVICE HAS NOT BEEN MADE AVAILABLE FOR REVIEW OR INVESTIGATION.

Description of Event or Problem · 0

THE DESCRIPTION IS TAKEN FROM MEDWATCH REPORT (B)(4). 'DRAGER INFINITY V500 VENTILATOR USING A FLEXICARE HEATER WITH DISPOSABLE, SINGLE USE TEMPERATURE PROBE WAS IN USE. THE RESPIRATORY THERAPIST NOTED AN ORANGE GLOW AND SIZZLE SOUND FOLLOWED BY A ONE SINGLE 'CHIRP' SOUND MADE BY THE VENTILATOR EQUIPMENT. INSTANTLY, FLAMES MELTED THE PLASTIC HOSES WHICH CONNECTED THE PATIENT TO THE VENTILATOR MACHINERY. THE PATIENT WAS IMMEDIATELY MOVED TO SAFETY, UNHARMED, AND VENTILATION WAS PROVIDED BY OXYGEN TANK AND AMBU-BAGGING. THE VENTILATOR EQUIPMENT FIRE WAS EXTINGUISHED QUICKLY BEFORE IT COULD SPREAD BEYOND THE SINGLE ROOM. SEVERAL HEALTHCARE WORKERS WERE EVALUATED IN THE EMERGENCY DEPARTMENT FOR POTENTIAL SMOKE INHALATION AND DUST FROM USE OF FIRE EXTINGUISHER EQUIPMENT. ALL INVOLVED EMPLOYEES WERE DISCHARGED HOME FROM THE EMERGENCY DEPARTMENT'.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
421741	FL9000U RESPIRATORY HUMIDIFIER HEATER 100-120V WITH NEMA 5 - 15P 3 PIN PLUG	RESPIRATORY HUMDIFIER HEATER	BTT	FLEXICARE MEDICAL LTD

Patients

Seq	Age	Sex	Outcome	Treatment
1	46 YR	Male