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

Model Number 159001

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/25/2020

Event Type  malfunction  

Event Description

Bedside nurse responded to the sound of disconnection on the vent.Nurse came to the bedside and saw the broken portion.Nurse held the pieces together, and called for assistance.Respiratory therapist came to the bedside to fix the broken g5 flow sensor, and suction valve while nurse bagged the patient.No harm to the patient because it was quickly recognized.

• Brand Name: HAMILTON-G5
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): HAMILTON MEDICAL AG; 4655 aircenter circle; reno NV 89502
• MDR Report Key: 11071836
• MDR Text Key: 223611593
• Report Number: 11071836
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 159001
• Device Catalogue Number: 159001
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/22/2020
• Event Location: Hospital
• Date Report to Manufacturer: 12/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1