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

Model Number FL9000U

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Patient Involvement (2645)

Event Date 02/04/2020

Event Type  malfunction  

Manufacturer Narrative

Device retained by hospital for their own investigation.

Event Description

Device was not in use.Heater unit was turned off, but still plugged into the wall and was sparking and had evidence of smoke/burning on it.

• Brand Name: RESPIRATORY HUMIDIFIER HEATER - 100-120V WITH NEMA 5-15P 3 PIN PLUG
• Type of Device: RESPIRATORY HUMDIFIER HEATER
• Manufacturer (Section D): FLEXICARE MEDICAL DONGGUAN LTD.; no. b-15 xicheng ind zone 1; hengli town; dongguan city, guangdong 52346 0; CH 523460
• MDR Report Key: 9779166
• MDR Text Key: 193009488
• Report Number: 3006061749-2020-00003
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 05055788768081
• UDI-Public: (01)05055788768081(10)FED11US1709166
• Combination Product (y/n): N
• PMA/PMN Number: K161314
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FL9000U
• Device Catalogue Number: FL9000U
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1