MAUDE Adverse Event Report: HAMILTON MEDICAL, INC HAMILTON-T1 INTELLIGENT TRANSPORT VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number T1

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Stacking Breaths (1593); Low Oxygen Saturation (2477)

Event Date 06/07/2020

Event Type  malfunction  

Event Description

Emergency medical service (ems) team attempted to do a critical care transport where a patient had to be placed on bilateral positive airway pressure (bipap).Patient tolerated the bipap well at the hospital, and on the ems hamilton vent in the hospital, and in the back of the ambulance initially.The ventilator was working perfectly despite the patient breathing rapidly at roughly 25-30 times a minute.Patient was loaded into the ambulance and transferred to truck oxygen (o2).Shortly after transferring to truck oxygen, the vent started to alarm that "oxygen supply failed." ems double checked both tanks were open and the tank switch was activated; confirmed they were.Patient's peripheral capillary oxygen saturation (sp02) began to rapidly decline.Ems switched the vent o2 line to the second tank and activated the switch; the vent continued to indicate that the "oxygen supply failed." ems activated both emergency by-pass oxygen valves.The vent continued to indicate that the "oxygen supply failed," as well as switching between "low oxygen," and "high oxygen," alerts multiple times and the patient's sp02 was rapidly declining.Ems performed set up on original port and attached a bag valve mask (bvm) at 15 lpm to it.The bvm reservoir bag was fully inflated and the ball indicator showed that the oxygen was flowing perfectly.Patient was bvmed successfully and sp02 decline halted, and then showed slight improvement.Patient diverted to closest facility as the patient was declining.The patient was initially suppose to go to a different facility, however ems figured they would not have enough oxygen in the spare portable tank to get to other facility while bagging the patient.Throughout transport ems could not get the saturations above 86%.Before the oxygen source was switched, the patient's saturations were above 90% on bipap.After the call, ems ran tests on the ventilator with the truck and the ventilator o2; pre-op check passed on both ports.The truck and the ventilator were taken out of service and brought to the garage.At the garage, ems team and supervisor attempted to use a vent circuit and vent balloon to recreate the issue using the same lines of trouble shooting as listed above (both ports, tank switch on and off, emergency oxygen valves opened and closed).No scenario was able to recreate the issue.The ventilator and truck were taken out of service.

• Brand Name: HAMILTON-T1 INTELLIGENT TRANSPORT VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): HAMILTON MEDICAL, INC; 4910 longley lane, suite 101; reno NV 89502
• MDR Report Key: 10217186
• MDR Text Key: 197112632
• Report Number: 10217186
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: T1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/30/2020
• Device Age: 20 MO
• Event Location: Other
• Date Report to Manufacturer: 07/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22995 DA