MAUDE Adverse Event Report: SPACELAB HEALTHCARE INC. ARKON; ANESTHESIA MACHINE

Device Problem Device Inoperable (1663)

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

Event Date 06/04/2018

Event Type  Injury  

Event Description

Anesthesia machine stopped working in middle of case in operating room.Evidently this is a known problem with this machine per spacelabs with no known fix.Their investigation has produced no root cause although it is happening all over the nation.There is a "fix" planned soon with no guarantees of success.They have provided us with a "workaround" when it occurs which in the current users guide.We have this guide posted in all operating rooms that currently use this product.Our meeting with spacelab's vice presidents today at our facility led us to the decision to replace these machines with a machine from another manufacturer.Spacelab informed me that they have self reported this issue with the fda.

• Brand Name: ARKON
• Type of Device: ANESTHESIA MACHINE
• Manufacturer (Section D): SPACELAB HEALTHCARE INC.
• MDR Report Key: 7613509
• MDR Text Key: 111646673
• Report Number: MW5077931
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• 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: 46 YR
• Patient Weight: 102