MAUDE Adverse Event Report: HAMILTON MEDICAL, INC. HAMILTON-G5; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number G5

Device Problem Device Emits Odor (1425)

Patient Problem Low Oxygen Saturation (2477)

Event Date 02/12/2017

Event Type  malfunction  

Event Description

Respiratory therapist entered the room to do a vent check and smelled a faint burning scent in the area of the ventilator.The patient began desaturating.The vent was unplugged and the smell immediately ceased.Vent was replaced with a different vent.The patient was bagged with no patient harm.

• Brand Name: HAMILTON-G5
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): HAMILTON MEDICAL, INC.; 4990 energy way; reno NV 89502
• MDR Report Key: 6348771
• MDR Text Key: 67941463
• Report Number: 6348771
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: G5
• Device Catalogue Number: 159001
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/13/2017
• Event Location: Hospital
• Date Report to Manufacturer: 02/13/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 1 YR
• Patient Weight: 6