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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SPACELABS HEALTHCARE XHIBIT CENTRAL STATION
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SPACELABS HEALTHCARE XHIBIT CENTRAL STATION Back to Search Results
Model Number 96102
Device Problem No Display/Image (1183)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/15/2023
Event Type  malfunction  
Manufacturer Narrative
A spacelabs healthcare technical support representative walked the user through restarting xhibit central station via hard reboot.Once rebooted, the display signal was restored and the customer confirmed the issue was resolved.Although restarting the xhibit central station resolved the reported issue, the cause of the video signal interruption could not be determined.
 
Event Description
The customer reported that the xhibit displays went blank while monitoring telemetry patients.There was no patient or user death, or injury associated with the event.
 
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Brand Name
XHIBIT CENTRAL STATION
Type of Device
XHIBIT CENTRAL STATION
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 Key17515951
MDR Text Key321074817
Report Number3010157426-2023-00062
Device Sequence Number1
Product Code MHX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122146
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 07/15/2023
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
Device Operator Health Professional
Device Model Number96102
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/15/2023
Initial Date FDA Received08/11/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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