MAUDE Adverse Event Report: SPACELABS HEALTHCARE XHIBIT CENTRAL STATION; CENTRAL STATION REMOTE MONITOR

Model Number 96102

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 12/03/2023

Event Type  malfunction  

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.Cause of failure was not determined.

Event Description

The customer reported that while monitoring patients on their xhibit central station, a black box appeared on the central and prevented the user from seeing patient data.There was no patient or user harm associated with this event.

• Brand Name: XHIBIT CENTRAL STATION
• Type of Device: CENTRAL STATION REMOTE MONITOR
• 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: 19218310
• MDR Text Key: 341500275
• Report Number: 3010157426-2024-00060
• 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: 12/03/2023

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 Model Number: 96102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2024
• Initial Date FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/09/2017
• 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