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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 10/31/2023
Event Type  malfunction  
Event Description
The customer reported that while monitoring patients, an xhibit central station display went blank.There was no patient or user harm associated with this event.
 
Manufacturer Narrative
A spacelabs field service engineer (fse) evaluated the customer system and isolated the issue to the video card.While on site, the fse also updated the software on the device and after observing proper device operation through functional and performance testing, the device was returned to the customer.The cause of the reported issue was due to the video card.
 
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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 Key18234973
MDR Text Key329329066
Report Number3010157426-2023-00101
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 10/31/2023
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? Device Returned to Manufacturer
Date Returned to Manufacturer11/02/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/31/2023
Initial Date FDA Received11/29/2023
Was Device Evaluated by Manufacturer? Yes
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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