MAUDE Adverse Event Report: MED ONE EQUIPMENT SERVICES, LLC HAMILTON G5 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number EIN 1238831

Device Problem Disconnection (1171)

Patient Problems Bradycardia (1751); Cardiac Arrest (1762)

Event Type  Injury  

Event Description

Icu rn heard vent alarming, red alarm flashing, went in to check on patient.Ett intact and connected to tubing.Traced tubing back to the machine and was noted that the inhalation port was disconnected.Immediately replaced.Patient went brady then lost pulse, immediately started cpr while code blue called, pea, epi, amiodarone, defib x 2 and rosc obtained.Ventilator tubing became disconnected from the ventilator, unknown why the tubing became disconnected from the ventilator.Hamilton g5 ventilator.Therapy start date (b)(6) 2021, therapy end date (b)(6) 2021.Fda safety report id # (b)(4).

• Brand Name: HAMILTON G5 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): MED ONE EQUIPMENT SERVICES, LLC ; 10712 s 1300 e ; sandy UT 84094
• MDR Report Key: 11463209
• MDR Text Key: 239471477
• Report Number: MW5099948
• Device Sequence Number: 1
• Product Code: CBK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EIN 1238831
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 73 YR
• Patient Weight: 72