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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OUTSET MEDICAL, INC. TABLO HEMODIALYSIS SYSTEM DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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OUTSET MEDICAL, INC. TABLO HEMODIALYSIS SYSTEM DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Device Problems Device Displays Incorrect Message (2591); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Insufficient Information (4580)
Event Date 01/07/2022
Event Type  malfunction  
Event Description
Unable to provide tx via tablo. Previous issues with tablo reported on day shift. Tablo tx unable to be provided despite multiple attempts to find solution. High venous pressure alarms despite new machines, new cartridges, new lines, and insight from on call tablo expert.
 
Event Description
No equipment issues or human factors interacting with equipment identified.
 
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Brand NameTABLO HEMODIALYSIS SYSTEM
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
OUTSET MEDICAL, INC.
3052 orchard drive
san jose CA 95134
MDR Report Key14249950
MDR Text Key290389759
Report Number14249950
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/19/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/29/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/19/2022
Event Location Hospital
Date Report to Manufacturer04/29/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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