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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 11/05/2023
Event Type  malfunction  
Manufacturer Narrative
A spacelabs field service engineer (fse) reached out to the customer.The fse reported that the device was removed from use and will be repaired.A follow up report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.
 
Event Description
The customer reported that while in use, an xhibit central station had blank displays.Both local displays and remote displays were affected.There was no patient or user harm associated with this event.
 
Manufacturer Narrative
The unit was shipped to spacelabs for depot repair.A equipment service technician tested the unit and identified a corrupted hard drive.The hard drive was replaced and the reported problem was resolved.Cause of failure was a corrupted hard drive.
 
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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 Key18271801
MDR Text Key329808194
Report Number3010157426-2023-00103
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,Followup
Report Date 11/05/2023
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
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/05/2023
Initial Date FDA Received12/05/2023
Supplement Dates Manufacturer Received11/13/2023
Supplement Dates FDA Received02/20/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/18/2019
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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