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	05/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that they experienced power disruption at their facility.When the power was restored, most patient monitoring resumed, however 18 telemetry patients were showing offline.A spacelabs healthcare field service engineer worked with the customer to perform troubleshooting of the xhibit telemetry receivers (xtr).Two different faulty xtrs were identified, all patients associated with the two xtrs were showing offline at the central station while showing waveforms at the receiver.The patients were transferred to different xtrs and the faulty xtrs were restarted.Following the restart, it was confirmed the network communication was restored, channels were able to be tuned and monitored and no further issues were observed.The logs from the xtrs and provided to a spacelabs healthcare product support specialist (pss).The pss identified that the two faulty xtrs lost network communication relating to the power disruption and restarted, however upon restart, the xtrs failed to establish connections due to a failure to properly restart.Once the xtrs were restarted again, the errors preventing the communication were resolved.
Additional Manufacturer Narrative
Additional xtr serial number relating to the network outage: (b)(6), (b)(4).

• 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: 22117188
• Report Number: 3010157426-2025-00099
• Device Sequence Number: 4251612
• Product Code: MHX
• UDI-Device Identifier: 10841522100246
• UDI-Public: (01)10841522100246
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/30/2025

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: 05/06/2025
• Initial Report FDA Received Date: 05/30/2025
• 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