MAUDE Adverse Event Report: GE GE VENTILATOR ADULT; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number 1505-9000-00

Device Problems Break (1069); Tidal Volume Fluctuations (1634)

Patient Problem Low Oxygen Saturation (2477)

Event Date 06/04/2019

Event Type  Injury  

Event Description

Pt on ventilator, ac 14, vt 500, peep 5.Pt exhaled tidal volume on ventilator decreased from 500ml to half.Flow sensor on vent failed.Pt taken off vent and bagged with 100% oxygen.Testing showed failed exhalation valve heater.Fda safety report id# (b)(4).

• Brand Name: GE VENTILATOR ADULT
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): GE
• MDR Report Key: 8716763
• MDR Text Key: 148734090
• Report Number: MW5087466
• 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: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1505-9000-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR