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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 Unexpected Shutdown (4019)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/18/2023
Event Type  malfunction  
Manufacturer Narrative
The xhibit central station was returned to spacelabs healthcare for repair.Upon initial inspection the technician noted that the device had an accumulation of dust.The dust caused intermittent functionality of the fan on the power supply.The unit was cleaned and the power supply was replaced.Following repair, the device passed all functional testing and was returned to the customer.The failure was due to a build up of dust that caused malfunction of the power supply fan.
 
Event Description
The customer reported that a xhibit central station (xsc) was repeatedly powering down.There was no patient or user harm associated with this event.
 
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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 Key18984118
MDR Text Key338711660
Report Number3010157426-2024-00051
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 12/18/2023
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 Model Number96102
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/27/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/18/2023
Initial Date FDA Received03/26/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/03/2021
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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