MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AVANCE; ANESTHESIA GAS MACHINE

Model Number 1009-9002-000

Device Problem Gas/Air Leak (2946)

Patient Problems Hypoventilation (1916); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Serial number: (b)(4).For 6 of the 6 reported events, a ge healthcare service representative performed a checkout of the system and confirmed the reported events.The bag arm hose was replaced to resolve 1 reported event, the adjustable pressure limit valve was replaced to resolve 1 event, the auxiliary common gas outlet output tube #104 was re-connected to resolve 1 event, the condenser e-z tubing was replaced to resolve 1 event, the o-ring at the co2 absorber connection to the circuit was replaced to resolve 1 event.For 1 event, replacement of the bellows and pop-off valve was recommended the customer.

Event Description

This report summarizes 6 malfunction events.A review of the events indicated that model 1009-9002-000 anesthesia gas machine experienced gas leaks.4 events were reported for a malfunction causing a leak of more than 4.5l per minute affecting ventilation, 2 events reported for a leak resulting in loss of ventilation.These reports were received from various sources.Of the 6 events, 5 did not involve a patient, and 1 did involve a patient.There was no patient information available.

Event Description

This report summarizes malfunction events.A review of the events indicated that model 1009-9002-000 anesthesia gas machine experienced gas leaks.3 events were reported for a malfunction causing a leak of more than 4.5l per minute affecting ventilation, 2 events reported for a leak resulting in loss of ventilation.These reports were received from various sources.Of the 6 events, 5 did not involve a patient, and 1 did involve a patient.There was no patient information available.

Manufacturer Narrative

Additional information was received that 1 device did not leak more than 4.5l/minute and therefore was not reportable.Serial number (s): (b)(4).For 5 of the 5 reported events, a ge healthcare service representative performed a checkout of the system and confirmed the reported events.The bag arm hose was replaced to resolve 1 reported event, the adjustable pressure limit valve was replaced to resolve 1 event, the auxiliary common gas outlet output tube #104 was re-connected to resolve 1 event, the condenser e-z tubing was replaced to resolve 1 event, the o-ring at the co2 absorber connection to the circuit was replaced to resolve 1 event.Additional information was received that 1 device did not leak more than 4.5l/minute and therefore was not reportable.Serial number: (b)(4).For 5 of the 5 reported events, a ge healthcare service representative performed a checkout of the system and confirmed the reported events.The bag arm hose was replaced to resolve 1 reported event, the adjustable pressure limit valve was replaced to resolve 1 event, the auxiliary common gas outlet output tube #104 was re-connected to resolve 1 event, the condenser e-z tubing was replaced to resolve 1 event, the o-ring at the co2 absorber connection to the circuit was replaced to resolve 1 event.

• Brand Name: AVANCE
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• MDR Report Key: 8488196
• MDR Text Key: 145236532
• Report Number: 2112667-2019-00075
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Number of Events Reported: 5
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 06/04/2019

1 Device was Involved in the Event

2 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1009-9002-000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/01/2019
• Initial Date FDA Received: 04/05/2019
• Supplement Dates Manufacturer Received: 05/03/2019
• Supplement Dates FDA Received: 06/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 0