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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SPACELABS HEALTHCARE INC. SPACELABS ULTRAVIEW SL COMMAND MODULE; ULTRAVIEW SL MULTIPARAMETER MODULE
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SPACELABS HEALTHCARE INC. SPACELABS ULTRAVIEW SL COMMAND MODULE; ULTRAVIEW SL MULTIPARAMETER MODULE Back to Search Results
Model Number 91496
Device Problem Device Alarm System (1012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/20/2021
Event Type  malfunction  
Manufacturer Narrative
Spacelabs has launched an investigation and will file a supplemental report when the investigation is complete.
 
Event Description
Spacelabs received a report on (b)(6) 2021 customer reported the command module failed to alarm for pause.No injury was reported with this event.
 
Manufacturer Narrative
No failure was found.The device historical data and device logs recognized a pause event with no corresponding alarm.It could not be determined that a malfunction occurred during this complaint episode.If additional information is provided, spacelabs will reassess the investigation.This investigation is considered complete and closed.
 
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Brand Name
SPACELABS ULTRAVIEW SL COMMAND MODULE
Type of Device
ULTRAVIEW SL MULTIPARAMETER MODULE
Manufacturer (Section D)
SPACELABS HEALTHCARE INC.
35301 se center st.
snoqualmie WA 98065
MDR Report Key11794652
MDR Text Key252205059
Report Number3010157426-2021-00026
Device Sequence Number1
Product Code DSI
Combination Product (y/n)Y
PMA/PMN Number
K103142
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 01/01/2005,08/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number91496
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
Date Manufacturer Received04/20/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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