MAUDE Adverse Event Report: SPACELABS HEALTHCARE XHIBIT CENTRAL STATION

Model Number 96102

Device Problem No Display/Image (1183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/08/2023

Event Type  malfunction  

Event Description

The customer contacted spacelabs technical support to report that while monitoring patients, the displays for the xhibit central station stopped functioning.There was no patient or user harm associated with this event.

Manufacturer Narrative

A spacelabs technical support representative advised the customer to perform a hard reboot of their system, but this did not resolve the reported issue.The customer was advised to either contact their biomedical engineer or have their local spacelabs field service engineer (fse) dispatched for additional investigation.The customer stated that they would call back at another time if needed.The spacelabs technical support representative called the site back after several hours and another user confirmed that the issue was resolved.The technical support representative attempted to contact the customer again to confirm what was done to resolve the reported issue; however, details were unknown.While the issue was confirmed to be resolved, the cause of the reported issue could not be determined.

• Brand Name: XHIBIT CENTRAL STATION
• Type of Device: XHIBIT CENTRAL
• Manufacturer (Section D): SPACELABS HEALTHCARE; 35301 se center st; snoqualmie WA 98065
• Manufacturer (Section G): SPACELABS HEALTHCARE; 35301 se center st; snoqualmie WA 98065
• Manufacturer Contact: whitney snyder ; 35301 se center st; snoqualmie, WA 98065
• MDR Report Key: 18089132
• MDR Text Key: 327606132
• Report Number: 3010157426-2023-00082
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/08/2023

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: 96102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/08/2023
• Initial Date FDA Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1