MAUDE Adverse Event Report: Spacelabs Healthcare Xhibit Central Station; Central Station Remote Monitor

Model Number	96102
Medical Device Problem Code	Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted spacelabs healthcare technical support to report that while monitoring telemetry patients, the patients would go offline for five to ten seconds every five to ten minutes.There was no report of patient or user harm associated with the event.Spacelabs technical support attempted to remotely connect to the xhibit telemetry receives (xtr) however were unable to connect or ping the devices.A spacelabs healthcare product & system integration specialist (psis) reached out to the customer to attempt to assist with troubleshooting the possible network disruption.At this time, the customer has not responded to the psis after numerous attempts.If additional information is made available, a follow-up report will be submitted in accordance with 21 cfr 803.56.

• Brand Name: Xhibit Central Station
• Common Device Name: Central Station Remote Monitor
• 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 ; +1(425)559-4957
• MDR Report Key: 50242085
• Report Number: 3010157426-2026-00137
• Device Sequence Number: 10366384
• Product Code: MHX
• UDI-Device Identifier: 10841522127069
• UDI-Public: (01)10841522127069
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K122146
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 08/13/2026

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: 96102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2026
• Initial Report FDA Received Date: 08/13/2026
• 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