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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 Problem Defective Alarm (1014)
Patient Problem Ventricular Tachycardia (2132)
Event Date 10/17/2019
Event Type  malfunction  
Manufacturer Narrative
Spacelabs has initiated an investigation into this matter.A supplemental report will be filed once the investigation is complete.
 
Event Description
Spacelabs received a report on (b)(6) 2019 regarding an allegation of failure to alarm for a ventricular tachycardia condition.
 
Manufacturer Narrative
No fault found upon investigation of the device historical database the monitor functioned as expected.The monitored is continued to be actively used at hospital location, no need for replacement.This report is complete, and this issue is considered closed.
 
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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
MDR Report Key9331808
MDR Text Key204702197
Report Number3010157426-2019-00040
Device Sequence Number1
Product Code MHX
Combination Product (y/n)Y
PMA/PMN Number
K112962
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 01/01/2005,06/17/2020
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
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
Initial Date Manufacturer Received 10/17/2019
Initial Date FDA Received11/15/2019
Supplement Dates Manufacturer Received01/14/2005
Supplement Dates FDA Received06/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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