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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE HEALTHCARE GE AISYS ANESTHESIA MACHINE

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GE HEALTHCARE GE AISYS ANESTHESIA MACHINE Back to Search Results
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.
 
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Brand NameGE AISYS
Type of DeviceANESTHESIA MACHINE
Manufacturer (Section D)
GE HEALTHCARE
1053 west grand ave
chicago IL 60642
MDR Report Key14855868
MDR Text Key295057126
Report Number14855868
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received06/20/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1011-9050-000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date05/28/2022
Event Location Hospital
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 06/20/2022 Patient Sequence Number: 1
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