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

Model Number 96102

Device Problem No Display/Image (1183)

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

Event Date 11/24/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Spacelabs received a report from the monitor tech that on (b)(6) 2021, the telemetry system went blank, and it did not came back.No injury was reported by the hospital for this event.

Manufacturer Narrative

The monitor was received at spacelabs¿ equipment service center for evaluation.The hard drive and power supply replaced resolving the reported issue.Monitor returned to customer site.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: marc rivas ; 35301 se center st.; snoqualmie, WA 98065 ; 4253635568
• MDR Report Key: 12981123
• MDR Text Key: 284815685
• Report Number: 3010157426-2021-00070
• 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: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,02/04/2022

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
• 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: 11/24/2021
• Initial Date FDA Received: 12/10/2021
• Supplement Dates Manufacturer Received: 11/24/2021
• Supplement Dates FDA Received: 02/04/2022
• 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