MAUDE Adverse Event Report: GE HEALTHCARE GE AISYS; ANESTHESIA MACHINE

Model Number 1011-9050-000

Device Problem No Pressure (2994)

Patient Problem Airway Obstruction (1699)

Event Date 04/27/2022

Event Type  malfunction  

Event Description

Pt arrived with leaking of amniotic fluid.On ultrasound she was oligohydramnios.The fetal heart rate was seen trending down to fetal bradycardia.Stat c-section was called.Baby girl born with an apgar score pf 8/8.The anesthesia provider reports to operating room team that he is having issues ventilating the patient.The ventilator had failed.The screen showed an error message showed "unable to drive bellows" and unable ventilate the patient.Patient was being manually ventilated with ambu bag.The patient was woken up in the operating room and taken to unit in stable condition.Ge service report confirmed machine acb inspiratory flow sensor error verified inspiratory pressure count.

• Brand Name: GE AISYS
• Type of Device: ANESTHESIA MACHINE
• Manufacturer (Section D): GE HEALTHCARE; 1053 west grand ave; chicago IL 60642
• MDR Report Key: 14855868
• MDR Text Key: 295057126
• Report Number: 14855868
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1011-9050-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/28/2022
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 19 YR
• Patient Sex: Female
• Patient Weight: 126 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White