MAUDE Adverse Event Report: GE HEALTH CARE / DATEX-OHMEDA, INC. OBS-S/5 ADVANCE CONFIGURATION - ANESTHESIA MACHINE; GAS-MACHINE, ANESTHESIA

Model Number ANBR00565

Device Problems Insufficient Flow or Under Infusion (2182); Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/31/2020

Event Type  No Answer Provided  

Event Description

Another device was needed to continue care; after induction of anesthesia and connecting the circuit from the anesthesia ventilator to the patient (patient 1), the oxygen flow went to zero.The anesthesia ventilator did not have enough oxygen flow to ventilate the patient.The patient was bagged and placed on a different anesthesia ventilator.The bag arm tube needed to be replaced and was replaced.The machine was placed back into service after evaluation by biomedical engineering.Four days later the same incident occurred.The patient (patient 2) was taken off the anesthesia ventilator and bagged.The ventilator was restarted and the flow was back to normal.The case was completed without incident.Prior to transfer from the operating room to the recovery room, the monitor screen on the anesthesia ventilator shut off and a portable ventilator was used to transport the patient to the recovery room.The patient (patient 2) remained stable.The anesthesia ventilator was taken out of service and the manufacturer was notified.

• Brand Name: OBS-S/5 ADVANCE CONFIGURATION - ANESTHESIA MACHINE
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): GE HEALTH CARE / DATEX-OHMEDA, INC.
• MDR Report Key: 10559825
• MDR Text Key: 207968424
• Report Number: MW5096760
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 10099002000
• UDI-Public: 1009-9002-000
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ANBR00565
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Weight: 74