MAUDE Adverse Event Report: DATEX-OHMEDA, INC TEC 6 PLUS; ANESTHESIA VAPORIZER

Device Problem Device Emits Odor (1425)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/09/2014

Event Type  malfunction  

Event Description

The hospital reported that, at the end of the case, the operating room circuit breaker tripped, and the unit was noted to have a burnt smell.There was no reported patient 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.Block a: under (b)(4) law, patient information is considered confidential and will not be released by the hospital.

Manufacturer Narrative

The hospital reported that, at the end of the case, the circuit breaker of the operating room tripped and there was a burnt smell noticed by the staff.The site electrician identified the vaporizer as the cause of the issue leading to the tripping of the circuit breaker.The vaporizer was sent to ge's depot repair facility for analysis.While at depot repair, when connecting the power cable to the connector on the device, sparks were noted on the electrical power connector of the device and inside it.The device was then returned to the manufacturing site for further investigation.The root cause for the reported complaint was a failed power supply; in particular the x-capacitor of the power supply.Visual inspection revealed that a capacitor on the power supply was burned, and the alleged smoke was generated from the failure of the capacitor.The capacitor has a 275 vac nominal rating, is rated from -40c to +110c, and is coated in flame retardant epoxy resin.This capacitor is mounted on a circuit board material meeting the ul 94v-0 flammability rating.The flame retardant material worked as designed, as there was no sustained ignition.

• Brand Name: TEC 6 PLUS
• Type of Device: ANESTHESIA VAPORIZER
• 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, IL 60010-3076 ; 8472774719
• MDR Report Key: 4421180
• MDR Text Key: 5418271
• Report Number: 2112667-2015-00002
• Device Sequence Number: 1
• Product Code: CAD
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K000275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2003
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1