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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SPACELABS HEALTHCARE XHIBIT CENTRAL STATION; CENTRAL STATION REMOTE MONITOR

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SPACELABS HEALTHCARE XHIBIT CENTRAL STATION; CENTRAL STATION REMOTE MONITOR Back to Search Results
Model Number 96102
Medical Device Problem Code Communication or Transmission Problem (2896)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 05/21/2026
Type of Reportable Event Malfunction
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.
 
Event or Problem Description
The customer contacted spacelabs healthcare technical support to report that the xhibit central station (xcs) was going offline for all beds for ten minutes before returning on its own.There was no report of patient or user harm associated with the event.Spacelabs technical support advised the customer that the issue indicated a possible network problem and to reach out to their internal networking team.At this time additional information is not available.If additional information is made available, a follow-up report will be submitted in accordance with 21 cfr 803.56.
 
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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
4255594957
MDR Report Key25553642
Report Number3010157426-2026-00104
Device Sequence Number21523262
Product Code MHX
UDI-Device Identifier10841522127069
UDI-Public(01)10841522127069
Combination Product (Y/N)N
Initial Reporter StateOK
Initial Reporter CountryUS
PMA/510(K) Number
K122146
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source Health Professional,User Facility
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 06/18/2026
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 Number96102
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 05/21/2026
Initial Report FDA Received Date06/18/2026
Was Device Evaluated by Manufacturer? (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 Number1
Patient SexUnknown
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