MAUDE Adverse Event Report: SPACELABS SPACELABS; ANESTHESIA MACHINE

Model Number ARKON 99999

Device Problems Loss of Power (1475); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/18/2017

Event Type  malfunction  

Event Description

During the surgical procedure, the arkon anesthesia machine's ventilator shut down and the machine unexpectedly entered a "failed state" mode.The anesthesia provider manually ventilated the patient as the machine was rebooted.After rebooting, the anesthesia machine returned to normal full operation with no resulting patient harm.

• Brand Name: SPACELABS
• Type of Device: ANESTHESIA MACHINE
• Manufacturer (Section D): SPACELABS
• MDR Report Key: 7128146
• MDR Text Key: 95324193
• Report Number: MW5074087
• 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: Nurse
• Type of Report: Initial
• Report Date: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARKON 99999
• 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