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

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).

• Brand Name: GE ANESTHESIA MACHINE AVANCE CS2
• Type of Device: GAS-MAHCINE, ANESTHESIA
• Manufacturer (Section D): GE HEALTHCARE/DATEX-OHMEDA, INC.
• MDR Report Key: 9641535
• MDR Text Key: 177024042
• Report Number: MW5092569
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: APDU01379
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 90 YR
• Patient Weight: 57