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

Model Number	PN-0006000
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Fire (1245); Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The outset medical engineering team reviewed the site system logs for the console at issue and verified there was no anomalous activity reflected in the logs that would have caused this event.The engineering team also performed a preliminary assessment of the console at the site and found no obvious source of cause.Additionally, extensive hardware testing has been performed since the event.Despite a thorough investigation, the testing did not reveal a root cause nor was the engineering team able to reproduce the failure under simulated conditions.As background, the tablo console is certified to the most recent iec 60601-1 3rd edition safety compliance standards.The consoles plastic enclosures have a v0 self-extinguishing rating.Further, a comprehensive dhr (device history record) review was performed.There were no non-conformances noted upon review of the dhr for the console at issue and it was confirmed that this console met all inspections and test criteria.Prior to final release and distribution to customers, all tablo consoles are inspected, tested and verified through in-process inspection and testing, followed by a quality inspection after manufacturing.Before the closure of every installation at a customer site, outset field service engineers performs a 9-point final inspection of the console.In conclusion, all of the analysis that outset has conducted to date suggests that this console was conforming to all applicable specifications.
Event or Problem Description
On (b)(6) 2021, a fire event involving a tablo console was reported.At the time of the event, the tablo console had been sitting idle in an unoccupied storage room.There was no patient involvement or reported injuries by the hospital staff as a result of this event.

• Brand Name: TABLO X HEMODIALYSIS SYSTEM
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): OUTSET MEDICAL, INC.; 3052 orchard drive; san jose CA 95134
• MDR Report Key: 12425209
• Report Number: 3010355846-2021-00070
• Device Sequence Number: 14298574
• Product Code: KDI
• UDI-Device Identifier: 00850001011112
• UDI-Public: (01)00850001011112(11)201204
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K190793
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: PN-0006000
• Device Catalogue Number: PN-0003000
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 08/05/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 09/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1