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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SPACELABS HEALTHCARE INC. SPACELABS XHIBIT CENTRAL STATION; XHIBIT CENTRAL MONITOR
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SPACELABS HEALTHCARE INC. SPACELABS XHIBIT CENTRAL STATION; XHIBIT CENTRAL MONITOR Back to Search Results
Model Number 96102
Device Problem Device Inoperable (1663)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/17/2018
Event Type  malfunction  
Manufacturer Narrative
Spacelabs has launched an investigation and will file a supplemental report when the investigation is completed.
 
Event Description
Spacelabs received a report that on (b)(6) 2018 the telemetry xhibit central monitor system became locked up.The xhibit rebooted itself, and telemetry monitoring resumed.No injury was reported as a result of this event.
 
Manufacturer Narrative
Spacelabs has reviewed the customer¿s system logs from the timeframe in question.Investigative findings indicated a large amount of system memory used.The issue was resolved when the xhibit was restarted.Memory issues for this customer have not been reported since this occurrence.This report is complete and this particular issue is considered to be closed.
 
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Brand Name
SPACELABS XHIBIT CENTRAL STATION
Type of Device
XHIBIT CENTRAL MONITOR
Manufacturer (Section D)
SPACELABS HEALTHCARE INC.
35301 se center st.
snoqualmie WA 98065
MDR Report Key7274530
MDR Text Key100518055
Report Number3010157426-2018-00017
Device Sequence Number1
Product Code MHX
Combination Product (y/n)Y
PMA/PMN Number
K122146
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 01/01/2005,12/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2018
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
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Date Report to Manufacturer01/10/2005
Date Manufacturer Received12/21/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
96280, 96281
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