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

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.

• Brand Name: TABLO SYSTEM
• Type of Device: SUBSYSTEM, WATER PURIFICATION
• Manufacturer (Section D): OUTSET MEDICAL, INC.
• MDR Report Key: 12548621
• MDR Text Key: 273849085
• Report Number: MW5104283
• Device Sequence Number: 1
• Product Code: FIP
• Number of Events Reported: 1
• 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 Received: 09/29/2021
• 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