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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SPACELABS HEALTHCARE INC. SPACELABS TELEMETRY RECEIVER MODULE
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SPACELABS HEALTHCARE INC. SPACELABS TELEMETRY RECEIVER MODULE Back to Search Results
Model Number 90478
Device Problem Defective Alarm (1014)
Patient Problem Ventricular Tachycardia (2132)
Event Date 08/30/2020
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) 2020 that a uvls tele bed did not alarm for vtach at the central but did in clinical access.No injury was reported in relation to this event.
 
Manufacturer Narrative
No fault found upon investigation of the device historical database the monitor functioned as expected.The device was tested for additional testing, reported issue could not be replicated.This report is complete, and this issue is considered closed.H3 other text : placeholder.
 
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Brand Name
SPACELABS TELEMETRY RECEIVER MODULE
Type of Device
TELEMETRY RECEIVER MODULE
Manufacturer (Section D)
SPACELABS HEALTHCARE INC.
35301 se center st.
snoqualmie WA 98065
MDR Report Key10556822
MDR Text Key213008014
Report Number3010157426-2020-00033
Device Sequence Number1
Product Code DSI
Combination Product (y/n)Y
PMA/PMN Number
K983996
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 01/01/2005,10/16/2020
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 Number90478
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 08/31/2020
Initial Date FDA Received09/18/2020
Supplement Dates Manufacturer Received01/14/2005
Supplement Dates FDA Received10/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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