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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OUTSET MEDICAL, INC. TABLO SYSTEM SUBSYSTEM, WATER PURIFICATION

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OUTSET MEDICAL, INC. TABLO SYSTEM SUBSYSTEM, WATER PURIFICATION Back to Search Results
Device Problems Fire (1245); Melted (1385)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  No Answer Provided  
Event Description
An investigation should be conducted on a tablo machine, manufactured by outset medical, that caught fire and melted down on its own at (b)(6) hospital on (b)(6) 2021. What is wrong with the machine? no one is giving answers at the hospital. This could have been super bad if someone had been standing next to it. A friend took this picture in the hospital but no one seems to care. Nurses and patients are in danger. I am afraid for my job.
 
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Brand NameTABLO SYSTEM
Type of DeviceSUBSYSTEM, WATER PURIFICATION
Manufacturer (Section D)
OUTSET MEDICAL, INC.
MDR Report Key12548621
MDR Text Key273849085
Report NumberMW5104283
Device Sequence Number1
Product Code FIP
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 09/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? 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

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