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

Device Problem Fire (1245)

Patient Problem Burn, Thermal (2530)

Event Date 10/22/2015

Event Type  Injury  

Manufacturer Narrative

Ge healthcare¿s investigation into the reported occurrence is still ongoing.A follow-up report will be issued when the investigation has been completed.Device evaluation anticipated, but not yet begun.

Event Description

The hospital reported that the patient incurred a first degree burn to the neck area due to a flash fire during a cauterization procedure and was treated with a burn cream.The anesthesia machine was only being used for delivery of oxygen via the auxiliary oxygen port.

Manufacturer Narrative

A ge healthcare service representative performed a checkout of the avance and found it to function within manufacturer¿s specifications.A review of the machine logs did not reveal any malfunction or device error that contributed to the reported fire.The hospital reported that 6 liters per minute (lpm) oxygen was in use along with a cautery device.The anesthesia patient safety foundation (apsf) fire prevention algorithm advises the use of oxygen concentrations below 30% to minimize risk of an operating room fire.The anesthesia machine is intended to be a continuously attended device used by clinicians trained in proper anesthesia delivery techniques.The anesthesia machine allows the clinician to set the fresh gas concentration to air to help prevent oxygen enrichment.Fresh gas oxygen concentration is under the control of the clinician, and the clinician has to balance fresh gas oxygen flow, patient uptake, breathing circuit leak, and gas analysis to maintain appropriate fio2.

• Brand Name: AVANCE
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda drive; madison WI 53718
• Manufacturer (Section G): DATEX-OHMEDA, INC.; 3030 ohmeda drive; madison WI 53718
• Manufacturer Contact: john szalinski ; 540 w. northwest highway; barrington; barrington, IL 60010
• MDR Report Key: 5213364
• MDR Text Key: 30853339
• Report Number: 2112667-2015-00213
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 10/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/1970
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR
• Patient Weight: 111