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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 Display or Visual Feedback Problem (1184)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/26/2018
Event Type  malfunction  
Manufacturer Narrative
Spacelabs has launched an investigation and will file a supplemental report once the investigation is complete.
 
Event Description
Spacelabs received a report on (b)(6) 2018 of a failure to alarm for pvcs on a telemetry patient. No injury was reported with this event.
 
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Brand NameSPACELABS TELEMETRY RECEIVER MODULE
Type of DeviceTELEMETRY RECEIVER MODULE
Manufacturer (Section D)
SPACELABS HEALTHCARE INC.
35301 se center st.
snoqualmie WA 98065
Manufacturer Contact
beth benner rn
35301 se center st.
snoqualmie, WA 98065
4253635568
MDR Report Key8112802
MDR Text Key128942344
Report Number3010157426-2018-00090
Device Sequence Number1
Product Code DSI
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K983996
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 01/01/2005,11/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number90478
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Event Location No Information
Date Report to Manufacturer01/10/2005
Date Manufacturer Received06/11/2018
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

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