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

Model Number 96102

Device Problem No Display/Image (1183)

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

Event Date 11/20/2023

Event Type  malfunction  

Event Description

The customer reported that one of their displays on their xhibit central station turned black, and they could not see their telemetry patients on the 4th floor.There was no report of patient or user harm associated with this event.

Manufacturer Narrative

A spacelabs healthcare technical support representative assisted the customer in transferring the patients on the blank display to one of the other functional displays and troubleshooting the issue.After the troubleshooting attempt, they were unable to resolve the reported display outage and requested they escalate the issue to their internal biomedical engineering department.A post market surveillance and safety manager later contacted the hospital's biomedical engineering department to gather additional information.The biomedical engineer confirmed that the issue had been resolved, and that it was isolated to the video splitter used on that display.Once the splitter was restarted, the device operated as expected.The cause of the reported issue was isolated to the hospital's video splitter.

• Brand Name: XHIBIT CENTRAL STATION
• Type of Device: CENTRAL STATION REMOTE RECEIVER
• 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: akshaya parmar ; 35301 se center st; snoqualmie, WA 98065 ; 4252958318
• MDR Report Key: 18359357
• MDR Text Key: 330909701
• Report Number: 3010157426-2023-00114
• 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: 11/20/2023

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 Operator: Health Professional
• Device Model Number: 96102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2023
• Initial Date FDA Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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