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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 Loss of Power (1475); Failure to Power Up (1476)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/09/2017
Event Type  malfunction  
Manufacturer Narrative
The device was sent to spacelabs healthcare for further analysis.The reported problem was verified.The power supply pcba was replaced.The repaired unit passed all functional tests and was restored to service.This report is complete and this particular issue is considered closed.
 
Event Description
Spacelabs received a report that on (b)(6) 2017, the qube monitor shut off while in use and would not power back on.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
daniel herrera
35301 se center st.
snoqualmie, WA 98065
4253635631
MDR Report Key6298695
MDR Text Key66667669
Report Number3010157426-2017-00015
Device Sequence Number1
Product Code MHX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K120616
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Biomedical Engineer
Remedial Action Repair
Type of Report Initial
Report Date 02/02/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/02/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number91390
Other Device ID NumberV3.05.10
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/09/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/24/2014
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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