MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON G5; TUBING, PRESSURE AND ACCESSORIES

Device Problems Tidal Volume Fluctuations (1634); Failure to Deliver (2338); Obstruction of Flow (2423)

Patient Problems Paralysis (1997); Low Oxygen Saturation (2477); Cough (4457)

Event Date 01/29/2023

Event Type  malfunction  

Event Description

In the morning, patient began coughing quite a bit, which had been occurring often over the past several days.During the previous shift that i had cared for the patient, i had to change the proximal flow sensor on the hamilton g5 vent 3 times due to excessive secretions in the flow sensor.The vent circuit with the sensor was in the appropriate position per manufacturer's recommendations to prevent secretion interference.The sensor was producing alerts for high and low tidal volumes, high and low minute volumes, check flow sensor and turn flow sensor alarms.Approximately 10 minutes later, patient started to desaturate to 70's with coughing and his respirations climbed to 50's despite 100% fio2 on ventilator.Writer removed patient from vent and manually ventilated to 100% spo2.Patient was returned to vent and immediately began to drop oxygen saturations again, while also receiving sedation.Once again, patient was manually bagged to 100%.Upon returning to ventilator, and after patient was also chemically paralyzed, the vent wouldn't cycle and deliver a breath.Writer immediately removed patient from ventilator & resumed bagging and called for a new ventilator.

• Brand Name: HAMILTON G5
• Type of Device: TUBING, PRESSURE AND ACCESSORIES
• Manufacturer (Section D): HAMILTON MEDICAL AG; 4655 aircenter circle; reno NV 89502
• MDR Report Key: 16459806
• MDR Text Key: 310438864
• Report Number: 16459806
• Device Sequence Number: 1
• Product Code: BYX
• 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: 01/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/30/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/01/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 9490 DA