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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE HEALTHCARE/DATEX-OHMEDA, INC. GE ANESTHESIA MACHINE AVANCE CS2 GAS-MAHCINE, ANESTHESIA

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GE HEALTHCARE/DATEX-OHMEDA, INC. GE ANESTHESIA MACHINE AVANCE CS2 GAS-MAHCINE, ANESTHESIA Back to Search Results
Lot Number APDU01379
Device Problems Burst Container or Vessel (1074); Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Hypoventilation (1916); Swelling (2091)
Event Date 01/14/2020
Event Type  Malfunction  
Event Description

The patient underwent direct laryngoscopy with biopsy of a laryngeal lesion under ga. Nearing the end of the procedure, the anesthesia machine failed to ventilate the patient, the bag blew up/stopped working. So, the patient was bagged. The patient also underwent tracheostomy placement after this event due to his laryngeal mass. This had nothing to do with the anesthesia machine event. Fda safety report id # (b)(4).

 
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Brand NameGE ANESTHESIA MACHINE AVANCE CS2
Type of DeviceGAS-MAHCINE, ANESTHESIA
Manufacturer (Section D)
GE HEALTHCARE/DATEX-OHMEDA, INC.
MDR Report Key9641535
MDR Text Key177024042
Report NumberMW5092569
Device Sequence Number1
Product Code BSZ
Combination Product (Y/N)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 01/24/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/28/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device LOT NumberAPDU01379
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 01/28/2020 Patient Sequence Number: 1
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