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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SPACELABS HEALTHCARE INC. SPACELABS XHIBIT CENTRAL STATION; S-CLASS CENTRAL MONITOR
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SPACELABS HEALTHCARE INC. SPACELABS XHIBIT CENTRAL STATION; S-CLASS CENTRAL MONITOR Back to Search Results
Model Number 96102
Device Problems Over-Sensing (1438); Loss of Power (1475)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/26/2016
Event Type  malfunction  
Manufacturer Narrative
The customer biomed was assisted by spacelabs technical support and the reported problem was verified.The power supply was replaced, which resolved the issue.Should additional information become available, a supplemental report will be filed.This report is considered complete and this particular issue closed.
 
Event Description
Spacelabs received a report that on (b)(6) 2016 the telemetry central xhibit became overheated and shut down during use.No injury was reported as a result of this event.
 
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Brand Name
SPACELABS XHIBIT CENTRAL STATION
Type of Device
S-CLASS CENTRAL 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 Key6265425
MDR Text Key65573537
Report Number3010157426-2017-00007
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
Reporter Occupation Biomedical Engineer
Remedial Action Repair
Type of Report Initial
Report Date 01/19/2017
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
Other Device ID NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/26/2016
Initial Date FDA Received01/19/2017
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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