MAUDE Adverse Event Report: UNKNOWN HFOV WATER CHAMBER; HUMIDIFIER

Model Number UNKNOWN

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 09/24/2014

Event Type  malfunction  

Event Description

Rt noticed white particles in water chamber of hfov circuit.Hfov taken off patient and chamber sent to lab for culture.Chamber was taken to lab by infection control.Reported particles were not growing.Disassembled chamber and all gaskets and parts were intact.Inspected circuit and no debris found.Nothing grew and we were unable to determine anything from the particles.Patient did not have any issue due to this.

• Brand Name: HFOV WATER CHAMBER
• Type of Device: HUMIDIFIER
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 4283063
• MDR Text Key: 22059508
• Report Number: 4283063
• Device Sequence Number: 0
• Product Code: BTT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2014
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/11/2014
• Event Location: Hospital
• Date Report to Manufacturer: 11/27/2014
• Patient Sequence Number: 0
• Patient Age: 1 MO