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

Model Number 96102

Device Problems Computer Software Problem (1112); Temperature Problem (3022)

Patient Problem Insufficient Information (4580)

Event Date 06/25/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation error logs indicated a recommendation to replace the video card as well as a third-party dell keyboard and lenovo mouse that is not compatible with this device per the ifu.Spacelabs fse replaced the recommended components.The device passed all tests, per slhc service procedures and was returned to service.This report is considered complete, and this matter closed.

Event Description

On june 28th, 2021, spacelabs received a report that on the (b)(6) 2021, around midnight, xhibit central station froze on a blue screen.At 00:53, the biomedical technician forced the shutdown.Then, the central station restarted properly.The biomedical tech noticed that the central station was very hot.Spacelabs received notification that the product specialist evaluated this issue and concluded it is a risk to a patient on (b)(6) 2021.No injury was reported with this event.

• Brand Name: SPACELABS XHIBIT CENTRAL STATION
• Type of Device: XHIBIT CENTRAL MONITOR
• Manufacturer (Section D): SPACELABS HEALTHCARE INC.; 35301 se center st.; snoqualmie WA 98065
• Manufacturer Contact: marc rivas ; 35301 se center st.; snoqualmie, WA 98065 ; 4253635568
• MDR Report Key: 12221881
• MDR Text Key: 265390074
• Report Number: 3010157426-2021-00045
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): Y
• Reporter Country Code: FR
• PMA/PMN Number: K122146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/01/2005,07/23/2021

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
• Device Catalogue Number: 96102-16C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 06/28/2021
• Initial Date FDA Received: 07/23/2021
• 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