MAUDE Adverse Event Report: SPACELABS HEALTHCARE XHIBIT CENTRAL STATION

Model Number 96102

Device Problem Application Program Freezes, Becomes Nonfunctional (4031)

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

Event Date 03/06/2024

Event Type  malfunction  

Event Description

The customer reported that while in use, the xhibit central station software blanked out.The customer was unable to see patient data or interact with the unit.There was no patient or user harm associated with this event.

Manufacturer Narrative

A spacelabs technical support representative walked the user through performing a hard reboot of the xhibit central station.Following the reboot, the customer confirmed the issue was resolved.While rebooting the xhibit resolved the issue, cause of failure was not established.

• 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: 18938057
• MDR Text Key: 338091422
• Report Number: 3010157426-2024-00035
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 10841522100345
• UDI-Public: 011084152210034511180612
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/06/2024

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: 03/06/2024
• Initial Date FDA Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/14/2018
• 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