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U.S. Department of Health and Human Services

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

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OUTSET MEDICAL, INC. TABLO CONSOLE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number PN-0006000
Device Problem Fire (1245)
Patient Problem Insufficient Information (4580)
Event Date 08/04/2021
Event Type  malfunction  
Event Description
A tablo hemodialysis console ignited in (b)(6) hospital. Patients had to be evacuated to other facilities. The sprinkler system contained the fire. I was not there--i found the report through the news (below) and the fire department. I have attached the fire investigation report, which identifies the tablo device (in section f, page 2) as the cause of ignition. The news story about the patient evacuations is here: (b)(6). Fda safety report id# fda safety report id # (b)(4).
 
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Brand NameTABLO CONSOLE
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
OUTSET MEDICAL, INC.
MDR Report Key12432477
MDR Text Key270066846
Report NumberMW5103723
Device Sequence Number1
Product Code KDI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Unknown
Type of Report Initial
Report Date 09/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPN-0006000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
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?
Type of Device Usage

Patient Treatment Data
Date Received: 09/07/2021 Patient Sequence Number: 1
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