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

Model Number 96102

Device Problem Complete Loss of Power (4015)

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

Event Date 12/06/2023

Event Type  malfunction  

Event Description

The customer reported that all their displays on their xhibit central station had gone blank.There was no patient or user harm associated with this event.

Manufacturer Narrative

A spacelabs technical support representative (tsr) assisted the customer, a biomedical engineer, in troubleshooting the reported event.The tsr had the customer restart their xhibit and displays but this did not resolve the reported issue.After troubleshooting was unsuccessful, the tsr provided the customer with an rma to return the device for further evaluation.A spacelabs healthcare equipment service center (esc) technician evaluated the device and was able to duplicate the reported issue.It was found that the fan on the video card had stopped functioning, and that the unit had an excessive amount of dust built up internally.The customer was advised of the findings, and that the unit would need to have the video card replaced and the internals thoroughly cleaned.The cause of the reported issue was due overheating caused by the excessive dust buildup and the failure of the video card fan.

• 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: 18422284
• MDR Text Key: 331673928
• Report Number: 3010157426-2023-00117
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 10841522127069
• UDI-Public: (01)10841522127069(11)190606
• 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: 12/06/2023

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2023
• Initial Date FDA Received: 12/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2019
• 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