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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 06/18/2023
Event Type  malfunction  
Event Description
The customer reported that while monitoring telemetry patients, the central station went down.There was no patient or user death, or injury associated with the event.
 
Manufacturer Narrative
Spacelabs healthcare's technical support representative advised the customer to power cycle the xhibit, which seemed to resolve the reported issue.A review of records indicates the issue has not reoccurred.Although restarting the system resolved the reported issue, the cause of the loss of monitoring could not be determined.
 
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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 Key17339492
MDR Text Key319270291
Report Number3010157426-2023-00054
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 Other Health Care Professional
Type of Report Initial
Report Date 06/18/2023
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 Operator Health Professional
Device Model Number96102
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/18/2023
Initial Date FDA Received07/17/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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