MAUDE Adverse Event Report: SPACELABS HEALTHCARE XHIBIT CENTRAL STATION

Model Number 96102

Device Problem Unexpected Shutdown (4019)

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

Event Date 12/18/2023

Event Type  malfunction  

Manufacturer Narrative

The xhibit central station was returned to spacelabs healthcare for repair.Upon initial inspection the technician noted that the device had an accumulation of dust.The dust caused intermittent functionality of the fan on the power supply.The unit was cleaned and the power supply was replaced.Following repair, the device passed all functional testing and was returned to the customer.The failure was due to a build up of dust that caused malfunction of the power supply fan.

Event Description

The customer reported that a xhibit central station (xsc) was repeatedly powering down.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: 18984118
• MDR Text Key: 338711660
• Report Number: 3010157426-2024-00051
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/18/2023

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2023
• Initial Date FDA Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2021
• 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