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

Model Number 96102

Device Problems Image Display Error/Artifact (1304); Telemetry Discrepancy (1629)

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

Event Date 11/27/2016

Event Type  malfunction  

Manufacturer Narrative

Spacelabs technical support guided the customer on performing a hard shutdown and restart to resume telemetry monitoring.A loaner device was put in place while the central station was sent in for repair.Spacelabs has launched an investigation and will file a supplemental report once the investigation is complete.

Event Description

Spacelabs received a report that on (b)(6) 2016, a blue screen was displaying on the xhibit central station and a loss of telemetry monitoring occurred.No injury was reported as a result of this event.

Manufacturer Narrative

The device was received at spacelabs for depot repair, and the reported problem was not reproducible.The device was tested in accordance with all relevant procedures.Normal device operation was verified and the device was returned to the customer.

• 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: marc rivas ; 35301 se center st.; snoqualmie, WA 98065 ; 4253635568
• MDR Report Key: 6202516
• MDR Text Key: 63558212
• Report Number: 3010157426-2016-00206
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/31/2017

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
• Other Device ID Number: 1.1.5.12725
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2016
• Initial Date FDA Received: 12/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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