MAUDE Adverse Event Report: SPACELABS HEALTHCARE XHIBIT TELEMETRY RECEIVER

Model Number	96280
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that while monitoring patients on a exhibit central station, the central lost all telemetry channels.There was no patient or user harm associated with this event.
Additional Manufacturer Narrative
A spacelabs technical support representative walked the user through performing a restart of the exhibit telemetry receiver.Following the restart, the customer confirmed the issue was resolved.Cause of failure was not determined.Note regarding b4, udi field: only the gtin information for the reported device was provided as the serial number was not available.

• Brand Name: XHIBIT TELEMETRY RECEIVER
• Common Device Name: TELEMETRY RECEIVER
• 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: 21230822
• Report Number: 3010157426-2025-00018
• Device Sequence Number: 18018347
• Product Code: MHX
• UDI-Device Identifier: 10841522100246
• UDI-Public: (01)10841522100246
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K141156
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 01/01/2025

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
• Operator of Device: Health Professional
• Device Model Number: 96280
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/01/2025
• Initial Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown