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

Model Number 96102

Device Problem Loss of Power (1475)

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

Event Date 02/13/2018

Event Type  malfunction  

Manufacturer Narrative

Spacelabs has launched an investigation and will file a supplemental report once the investigation is complete.

Event Description

Spacelabs received a report on (b)(6) 2018 of a xhibit central monitoring telemetry patients experienced a video outage on all four monitors.No injury was reported with this event.

Manufacturer Narrative

The field service engineer completed an onsite investigation of the xhibit central station and the device logs were evaluated by spacelabs¿ product support specialist.Investigative findings conclude a performance issue caused the reported event.Performing a hard reset of the system resolved the issue.The field service engineer ensured the xhibit central station was operating according to specifications.This report is complete and this particular issue is considered closed.

• 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: michael frey ; 35301 se center st.; snoqualmie, WA 98065 ; 425 363-56
• MDR Report Key: 7327007
• MDR Text Key: 102104390
• Report Number: 3010157426-2018-00032
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/11/2018

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: 02/13/2018
• Initial Date FDA Received: 03/09/2018
• Supplement Dates Manufacturer Received: 02/13/2018
• Supplement Dates FDA Received: 05/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2016
• 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