MAUDE Adverse Event Report: SPACELABS HEALTHCARE LTD. SPACELABS; ANESTHESIA MACHINE

Model Number ARKON 99999

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 08/30/2017

Event Type  malfunction  

Event Description

During a surgical procedure, the arkon anesthesia machine's bag/vent switch failed to switch over from the bag mode to the vent mode when it was moved to the vent position.The bellows/vent never engaged and the provider had to manually bag the patient until the anesthesia machine was swapped out with a spare machine.

• Brand Name: SPACELABS
• Type of Device: ANESTHESIA MACHINE
• Manufacturer (Section D): SPACELABS HEALTHCARE LTD.
• MDR Report Key: 7124287
• MDR Text Key: 95217882
• Report Number: MW5074037
• 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

• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/15/2017
• 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