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 03/03/2024

Event Type  malfunction  

Manufacturer Narrative

The customer stated every time they closed the window, the software would reboot.Spacelabs technical support walked the user through both a software and hardware reset, however it did not resolve the failure.The user stated they would reach out to their biomed team to get a spare unit.Tech support has attempted to call the customer back for additional information and confirm resolution.At this time the customer has not returned calls.If additional information is made available, a follow up report will be submitted in accordance with 21 cfr 803.56.

Event Description

The customer reported that while monitoring patients, the xhibit central station locked up and became unresponsive.The user had restarted the central to resume monitoring, however, upon restart there was a application window that was present and would not disappear and prevented the user from being able to view patient waveforms.There was no patient or user harm associated with this event.

• 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: 18984117
• MDR Text Key: 338752699
• Report Number: 3010157426-2024-00048
• 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: 03/03/2024

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: 03/03/2024
• Initial Date FDA Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: No
• 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