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U.S. Department of Health and Human Services

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

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OUTSET MEDICAL, INC. TABLO HMODIALYZER DIALYZER, HIGH PERMABILITY 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 01/17/2020
Event Type  Injury  
Event Description
During routine dialysis treatment tablo dialyzer powered down. Patient¿s blood returned via hand crank. Dialysis treatment needed to be stopped related to equipment shut down. No signs/symptoms of pain or adverse effects. Required intervention to prevent patient from blood loss. Fda safety report id # (b)(4).
 
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Brand NameTABLO HMODIALYZER
Type of DeviceDIALYZER, HIGH PERMABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
OUTSET MEDICAL, INC.
MDR Report Key9641568
MDR Text Key176973874
Report NumberMW5092571
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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