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	04/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted spacelabs healthcare technical support to report that they lost sixteen telemetry patients across all central stations.There was no report of patient or user harm associated with the event.A spacelabs healthcare technical support representative remotely connected and verified that the telemetry channels were no longer online.Technical support advised the customer that one of the xhibit telemetry receivers (xtr) appear to have gone offline.To resume monitoring, technical support recommended the customer readmit the patients.The customer was advised to have a biomed inspect the xtr.Several follow up attempts were made for additional information, however no response has been received at this time.If additional information is made available, a follow-up report will be submitted in accordance with 21 cfr 803.56.
Additional Manufacturer Narrative
Note regarding d4, 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: 25049237
• Report Number: 3010157426-2026-00084
• Device Sequence Number: 16044737
• Product Code: MHX
• UDI-Device Identifier: 10841522100246
• UDI-Public: (01)10841522100246
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/30/2026

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: 04/04/2026
• Initial Report FDA Received Date: 04/30/2026
• 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