MAUDE Adverse Event Report: Outset Medical, Inc. Tablo Hemodialysis System; Dialyzer, High Permeability With Or Without Sealed Dialysate System

Catalog Number	PN-0006000
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the power entry module overheated due to loose connection.No patient was involved.
Additional Manufacturer Narrative
An outset medical, inc.Field service engineer (fse) evaluated the device on-site, inspected the power cord and confirmed the reported complaint.The fse replaced the power cord.The actual device was not returned.Based on the available information and investigation findings, the probable root cause was mechanical manipulation of the power cord, resulting in a partially seated electrical connection, increased electrical resistance and heating of the connector contacts, which led to progressive connector degradation and thermal damage.Appropriate corrective actions have been initiated.A review of production records for this serial number did not note any related manufacturing nonconformances that would contribute to this event.

• Brand Name: Tablo 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
• Manufacturer (Section G): Outset Medical, Inc.; 3052 orchard drive; san jose CA 95134
• Manufacturer Contact: dinamarie stefani ; 3052 orchard drive; san jose, CA 95134 ; +1(669)231-8200
• MDR Report Key: 50812447
• Report Number: 3010355846-2026-00121
• Device Sequence Number: 8644018
• Product Code: KDI
• UDI-Device Identifier: 00850001011204
• UDI-Public: (01)00850001011204(11)220310
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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: Health Professional
• Device Catalogue Number: PN-0006000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/10/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown