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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SPACELABS HEALTHCARE INC. SPACELABS QUBE COMPACT MONITOR
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SPACELABS HEALTHCARE INC. SPACELABS QUBE COMPACT MONITOR Back to Search Results
Model Number 91390
Device Problems Use of Incorrect Control/Treatment Settings (1126); Display or Visual Feedback Problem (1184); Unexpected Shutdown (4019)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/23/2021
Event Type  malfunction  
Manufacturer Narrative
No patient data lost.Spacelabs depot service repair verified the reported problem.The device was repaired and tested in accordance with spacelabs service procedures.This report is considered complete and this particular issue closed.
 
Event Description
Spacelabs received a report that on (b)(6) 2021 the bedside monitor shut off during a case.When biomed responded he found the biomed menu was inaccessible and the monitor's configurations was set to defaults.No injury was reported as a result of this event.
 
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Brand Name
SPACELABS QUBE COMPACT MONITOR
Type of Device
QUBE COMPACT MONITOR
Manufacturer (Section D)
SPACELABS HEALTHCARE INC.
35301 se center st.
snoqualmie WA 98065
Manufacturer Contact
marc rivas
35301 se center st.
snoqualmie, WA 98065
4253635568
MDR Report Key11682415
MDR Text Key248184369
Report Number3010157426-2021-00022
Device Sequence Number1
Product Code MHX
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K120616
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 01/01/2005,04/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number91390
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Date Report to Manufacturer01/10/2005
Date Manufacturer Received03/23/2021
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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