MAUDE Adverse Event Report: SPACELABS HEALTHCARE XHIBIT TELEMETRY RECEIVER

Model Number	96280
Medical Device Problem Code	Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Note regarding b4, udi field: only the gtin information for the reported device was provided as the serial number was not available.
Event or Problem Description
The customer reported that while monitoring telemetry patients on a xhibit central station (xcs), all patients went offline.Spacelabs healthcare technical support walked the user through restarting the xcs and the customer stated that bedside patients returned, however, telemetry patients continued to show offline.The customer later identified that the xhibit telemetry receiver (xtr) was found to be off.Once the device was powered back on, the missing telemetry patients reappeared at the xcs.Logs were collected from two different xtrs.At this time, the logs have not been reviewed to determine cause of failure.If additional information is made available, a follow up report will be submitted in accordance with 21 cfr 803.56.
Additional Manufacturer Narrative
Logs were reviewed by a spacelabs healthcare product support specialist (pss).The logs indicate that two different xhibit telemetry receivers (xtr) experienced a power outage.One xtr automatically recovered once power was restarted, while the other xtr did not recover and remained powered off until a user had manually powered on the receiver.The cause of the power bump was not determined.

• 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: 22294659
• Report Number: 3010157426-2025-00101
• Device Sequence Number: 8374036
• Product Code: MHX
• UDI-Device Identifier: 10841522100246
• UDI-Public: (01)10841522100246
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,Followup
• Report Date (Section B): 06/19/2025

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: 05/21/2025
• Supplement Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 07/03/2025
• 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