MAUDE Adverse Event Report: SPACELABS SPACELABS ARKON; ANESTHESIA MACHINE

Model Number ARKON 99999

Device Problem No Display/Image (1183)

Patient Problem No Code Available (3191)

Event Date 07/26/2017

Event Type  malfunction  

Event Description

During the surgical procedure, the arkon anesthesia machine display unit was unable to read/display the co2 values.A portable rgm was brought into the room to complete the case with.After the case, the machine was removed from service until the gas analyzer was recalibrated/tested/cleared by biomed.

• Brand Name: SPACELABS ARKON
• Type of Device: ANESTHESIA MACHINE
• Manufacturer (Section D): SPACELABS
• MDR Report Key: 7120654
• MDR Text Key: 95077168
• Report Number: MW5073981
• 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: 12/14/2017
• 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