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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SPACELABS HEALTHCARE INC. SPACELABS XPREZZON BEDSIDE MONITOR; S-CLASS MULTIPARAMETER PATIENT MONITOR
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SPACELABS HEALTHCARE INC. SPACELABS XPREZZON BEDSIDE MONITOR; S-CLASS MULTIPARAMETER PATIENT MONITOR Back to Search Results
Model Number 91393
Device Problems Poor Quality Image (1408); Loss of Power (1475); Device Stops Intermittently (1599)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/15/2016
Event Type  malfunction  
Manufacturer Narrative
The product was received at spacelabs¿ equipment service center for repair.The reported problem was verified , and the power supply pcba and novram were replaced.The repaired unit passed all functional tests and was returned to the customer.This report is complete and this particular issue is considered closed.
 
Event Description
Spacelabs received a complaint that bedside monitor displayed a green screen and intermittently shut off lasting more than a minute while in use.No injury was reported.
 
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Brand Name
SPACELABS XPREZZON BEDSIDE MONITOR
Type of Device
S-CLASS MULTIPARAMETER PATIENT 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 Key6167790
MDR Text Key62435332
Report Number3010157426-2016-00194
Device Sequence Number1
Product Code MHX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112962
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Biomedical Engineer
Remedial Action Repair
Type of Report Initial
Report Date 12/12/2016
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 Number91393
Other Device ID NumberV3.04.00
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/15/2016
Initial Date FDA Received12/12/2016
Was Device Evaluated by Manufacturer? Yes
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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