MAUDE Adverse Event Report: DRAGER FABIUS TIRO; ANESTHESIA MACHINE

Model Number FABIUS TIRO

Device Problems Improper or Incorrect Procedure or Method (2017); No Fail-Safe Mechanism (2990)

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

Event Date 07/24/2014

Event Type  Injury  

Event Description

Pt was given a general anesthetic for an endoscopic retrograde cholangiopancreatography (ercp).The anesthesia machine was a drager fabius tiro equipped with a one vaporizer arrangement but a rack to hold a second exchangeable vaporizer ( to use either desflurane or sevoflurane).This was a new, second fabius tiro anesthesia machine for the dept; the original machine did not have the holding rack for the second vaporizer.The second vaporizer in the non-functional position was in close proximity to the functional one, and the dials on either vaporizer could be turned and adjusted (i.E., no locking mechanism or other warning to prevent turning on the non-functional vaporizer).The anesthesia provider was unaware that the second vaporizer was not functional in it's position, and thinking he could use either vaporizer, chose the non-functional one.In the recovery room the pt described being awake but unable to move during the ercp procedure.In retrospect, better reduction could have been done regarding the new anesthesia machine features including the rail holding the spare vaporizer and the fact that it was non-functional.The anesthesia provider did have an agent analyzer, but failed to note the absence of agent.The vendor (drager) was contacted to inquire about any locking mechanism or special labeling they provide to prevent inadvertent use of the non-functional vaporizer - they have nothing.We have educated all the anesthesia providers and have removed the spare vaporizer from the machine until we device a safety mechanism that either prevents turning the dial on the non-functional vaporizer, or clearly labels it as non-functional.We believe this is a pt safety issue and design flaw that needs to be corrected by the manufacturer.In contrast to the historical design advances in the safety of anesthesia machines over the years, the layout on this anesthesia machine is lacking safety features (locking mechanism or clear labeling) that would prevent a provider from thinking he had turned on an active anesthesia vaporizer.

• Brand Name: FABIUS TIRO
• Type of Device: ANESTHESIA MACHINE
• Manufacturer (Section D): DRAGER; telford PA 18969
• MDR Report Key: 4080811
• MDR Text Key: 4827235
• Report Number: MW5038115
• Device Sequence Number: 1
• Product Code: BSZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FABIUS TIRO
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Weight: 57