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U.S. Department of Health and Human Services

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

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OUTSET MEDICAL, INC. TABLO HEMODIALYZER DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number TABLO CONSOLE
Device Problem Loss of Power (1475)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/20/2020
Event Type  Injury  
Event Description
During dialysis treatment tablo dialyzer turned off during the treatment. Patient¿s treatment was discontinued and patient¿s blood was returned to the patient via hard crank. Patient awake and alert with no signs or symptoms of distress. Nursing supervisor, physician and tablo representative were notified of the equipment power failure. No power failure in the building. No injury or adverse effects to the patient. Fda safety report id # (b)(4).
 
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Brand NameTABLO HEMODIALYZER
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
OUTSET MEDICAL, INC.
MDR Report Key9641558
MDR Text Key177024622
Report NumberMW5092570
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTABLO CONSOLE
Device Catalogue NumberPN-003000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 01/28/2020 Patient Sequence Number: 1
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