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

Model Number 96102

Device Problem Loss of Power (1475)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/21/2017

Event Type  malfunction  

Manufacturer Narrative

Spacelabs technical support assisted the customer remotely during the event.Power cycling the exhibit and moving the display cables to different ports on the video card resolved the problem.The customer confirmed that the displays were working as expected.There have been no reports of recurrence.This report is considered complete and this matter closed.

Event Description

Spacelabs received a report that on (b)(6) 2017, following a facility power loss, both of the displays at the telemetry central monitor lost the monitored data and waveform display.No injury was reported as a result of this incident.

• Brand Name: SPACELABS XHIBIT CENTRAL STATION
• Type of Device: S-CLASS CENTRAL MONITOR
• Manufacturer (Section D): SPACELABS HEALTHCARE INC.; 35301 se center st.; snoqualmie WA 98065
• Manufacturer Contact: carolyn hosea ; 35301 se center st.; snoqualmie, WA 98065 ; 4253635924
• MDR Report Key: 6804074
• MDR Text Key: 83249234
• Report Number: 3010157426-2017-00062
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/18/2017

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
• Initial Date Manufacturer Received: 07/21/2017
• Initial Date FDA Received: 08/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2016
• 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