MAUDE Adverse Event Report: SPACELABS HEALTHCARE XHIBIT TELEMETRY RECEIVER

Model Number 96280

Device Problem Communication or Transmission Problem (2896)

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

Event Date 03/06/2024

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) was paged to go on site to investigate and resolve the failure, however, the customer called back stating that they resolved the failure by restarting the xhibit telemetry receiver (xtr) and confirmed that it resolved the issue and stated the fse was no longer needed on site.While restarting the xtr resolved the failure, cause of failure was not established.

Event Description

The customer reported that they were unable to monitor their telemetry patients at a xhibit central station.During the outage the clinical staff were manually monitoring the patients.There was no patient or user harm associated with this event.

• Brand Name: XHIBIT TELEMETRY RECEIVER
• Type of Device: XHIBIT TELEMETRY
• 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: 18956613
• MDR Text Key: 338735626
• Report Number: 3010157426-2024-00042
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141156
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 96280
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: No
• 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