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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
Device Problem Unexpected Shutdown (4019)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/14/2024
Event Type  malfunction  
Event Description
The customer reported that while monitoring patients, the xhibit central station crashed preventing the clinicians ability to monitor telemetry patients.There was no patient or user harm associated with this event.
 
Manufacturer Narrative
A spacelabs field service engineer (fse) went on site and inspected the xhibit central station.The fse stated that following a hard reboot the device was functional, however the unit had a build up of dust.The fse cleaned out the unit and reloaded the software.Following the maintenance on the unit, no further issues have been reported with this device.Cause of failure was not identified, however it was suspected that the unit was overheating due to dust inside the unit.
 
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Brand Name
XHIBIT CENTRAL STATION
Type of Device
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
MDR Report Key19093877
MDR Text Key340685861
Report Number3010157426-2024-00056
Device Sequence Number1
Product Code MHX
UDI-Device Identifier10841522127069
UDI-Public0110841522127069
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 03/14/2024
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? Device Returned to Manufacturer
Date Returned to Manufacturer03/15/2024
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/14/2024
Initial Date FDA Received04/11/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/18/2023
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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