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

Model Number 96102

Device Problems No Display/Image (1183); Unexpected Shutdown (4019)

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

Event Date 04/07/2024

Event Type  malfunction  

Manufacturer Narrative

The unit was received by spacelabs healthcare and was tested by an equipment service center technician and the problem was verified.The technician stated that the unit had a faulty fan on the video card and power supply.At this time the unit cannot be repaired due to the age of their device and part obsolescence and their xhibit central station was no longer repairable, and that they would need to replace the device.The customer will be offered option to purchase a new or refurbished unit.

Event Description

The customer reported that while monitoring telemetry patients, the xhibit central station displays suddenly powered off, following the display outage, the xhibit stopped functioning altogether and would no longer power on.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: 19218312
• MDR Text Key: 341500334
• Report Number: 3010157426-2024-00067
• 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: 04/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2024
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2018
• 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