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

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).

• Brand Name: TABLO CONSOLE
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): OUTSET MEDICAL, INC.
• MDR Report Key: 12432477
• MDR Text Key: 270066846
• Report Number: MW5103723
• Device Sequence Number: 1
• Product Code: KDI
• Number of Events Reported: 1
• 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 Received: 09/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PN-0006000
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other