MAUDE Adverse Event Report: SPACELABS HEALTHCARE XHIBIT CENTRAL STATION

Model Number 96102

Device Problem Communication or Transmission Problem (2896)

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

Event Date 01/26/2024

Event Type  malfunction  

Manufacturer Narrative

The customer stated that while telemetry monitoring was unavailable, clinical staff manually monitored staff.Tech support walked the user through restarting their xhibit central station.Following the restart, the patient zones were unassigned, tech support walked the user through reassigning patient zones to continue monitoring.While patient monitoring was resumed, cause of failure was not established.

Event Description

The customer reported that several telemetry beds went offline while monitoring patients.There was no patient or user harm associated with this event.

• Brand Name: XHIBIT CENTRAL STATION
• Type of Device: XHIBIT CENTRAL
• Manufacturer (Section D): SPACELABS HEALTHCARE; 35301 se center st; snoqualmie WA 98065
• Manufacturer (Section G): SPACELABS HEALTHCARE; 35301 se center st; snoqualmie WA 98065
• Manufacturer Contact: whitney snyder ; 35301 se center st; snoqualmie, WA 98065
• MDR Report Key: 18744456
• MDR Text Key: 335854141
• Report Number: 3010157426-2024-00029
• 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
• Report Date: 01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 96102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/15/2019
• 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