MAUDE Adverse Event Report: FLEXICARE MEDICAL LTD FL9000U RESPIRATORY HUMIDIFIER HEATER 100-120V WITH NEMA 5 - 15P 3 PIN PLUG; RESPIRATORY HUMDIFIER HEATER

Catalog Number FL9000U

Device Problem Fire (1245)

Patient Problem Insufficient Information (4580)

Event Date 05/18/2022

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

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'.

• Brand Name: FL9000U RESPIRATORY HUMIDIFIER HEATER 100-120V WITH NEMA 5 - 15P 3 PIN PLUG
• Type of Device: RESPIRATORY HUMDIFIER HEATER
• Manufacturer (Section D): FLEXICARE MEDICAL LTD; cynon valley business park; mountain ash, CF45 4ER; UK CF45 4ER
• Manufacturer (Section G): FLEXICARE MEDICAL DONGGUAN; no.b-15 xicheng ind. zone 1; hengli town; dongguan city, guangdong 52346 0; CH 523460
• Manufacturer Contact: julie davies ; cynon valley business park; mountain ash, CF45 -4ER ; UK CF45 4ER
• MDR Report Key: 14860634
• MDR Text Key: 295115391
• Report Number: 3006061749-2022-00012
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FL9000U
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/31/2022
• Initial Date FDA Received: 06/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: 1402800000-2022-8001
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Race: White