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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 Application Program Freezes, Becomes Nonfunctional (4031)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/18/2024
Event Type  malfunction  
Event Description
The customer contacted spacelabs technical support to report that while in use the license for a xhibit central station was lost and all telemetry patients being monitored were no longer able to be monitored.There was no patient or user harm associated with this event.
 
Manufacturer Narrative
The customer stated the unit had lost its license after a hard reboot.A field service engineer (fse) went on site and relicensed the xhibit and performed a functional check.The fse confirmed the device was functional and the unit was put back in use.While relicensing the xhibit resolved the failure, cause of failure was no established.
 
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Brand Name
XHIBIT CENTRAL STATION
Type of Device
XHIBIT CENTRAL
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 Key18794231
MDR Text Key337510805
Report Number3010157426-2024-00031
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 02/18/2024
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 02/18/2024
Initial Date FDA Received02/27/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/29/2016
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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