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

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 11/15/2017

Event Type  malfunction  

Event Description

During a surgical procedure, the arkon anesthesia machine display unit displayed the error message "gas analyzer failure." 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 bench was replaced/tested/cleared by biomed.

• Brand Name: SPACELABS
• Type of Device: ANESTHESIA MACHINE
• Manufacturer (Section D): SPACELABS HEALTHCARE INC.
• MDR Report Key: 7124276
• MDR Text Key: 95190457
• Report Number: MW5074025
• 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: 12/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1