MAUDE Adverse Event Report: SPACELABS HEALTHCARE XHIBIT CENTRAL STATION

Model Number 96102

Device Problem No Display/Image (1183)

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

Event Date 09/08/2023

Event Type  malfunction  

Event Description

The customer contacted spacelabs technical support to report that while monitoring patients, two displays for the xhibit central station lost video signal.There was no patient or user harm associated with this event.

Manufacturer Narrative

A spacelabs field service engineer (fse) contacted the customer to gather additional information.The fse advised the customer to verify the video input signal was correct, however the biomed was not on site at that time and stated that he would do it in the morning.The fse followed up with the customer the next day and the customer confirmed that the issue was resolved, but they did not know what was specifically done to resolve the problem.Although the issue was confirmed to have been resolved, the cause could not be conclusively determined as the customer was not sure what was done to resolve the problem.

• Brand Name: XHIBIT CENTRAL STATION
• Type of Device: XHIBIT CENTRAL STATION
• 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: 17873704
• MDR Text Key: 324975006
• Report Number: 3010157426-2023-00076
• 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: 09/08/2023

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: Not provided
• Initial Date FDA Received: 10/04/2023
• 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