MAUDE Adverse Event Report: FLEXICARE USA FLEXICARE FL - 9000U RESPIRATORY HUMIDIFIER BASE ; RES. HUMIDIFIER BASE

Model Number FL-9000U

Device Problem Melted (1385)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/09/2017

Event Type  malfunction  

Event Description

Respiratory therapist discovered vent circuit melted.Vent circuit was connected to the pt at the time of discovery.Pt was off the ventilator.The vent circuit was on the bed.The heater was on but the ventilator was off.We are unsure of this is due to the humidifier or the circuit.

• Brand Name: FLEXICARE FL - 9000U RESPIRATORY HUMIDIFIER BASE
• Type of Device: RES. HUMIDIFIER BASE
• Manufacturer (Section D): FLEXICARE USA; irvine CA 92618
• MDR Report Key: 6812590
• MDR Text Key: 83507701
• Report Number: MW5071737
• 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: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/21/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FL-9000U
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 12 YR
• Patient Weight: 34