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

Model Number	FL9000U
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device retained by hospital for their own investigation.
Event or Problem 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
• Common Device Name: RESPIRATORY HUMDIFIER HEATER
• MDR Report Key: 9779166
• Report Number: 3006061749-2020-00003
• Device Sequence Number: 469267
• Product Code: BTT
• UDI-Device Identifier: 05055788768081
• UDI-Public: (01)05055788768081(10)FED11US1709166
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/03/2020

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
• Operator of Device: Health Professional
• Device Model Number: FL9000U
• Device Catalogue Number: FL9000U
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 03/03/2020
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1