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U.S. Department of Health and Human Services

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

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OUTSET MEDICAL, INC. TABLO X HEMODIALYSIS SYSTEM DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number PN-0006000
Device Problems Thermal Decomposition of Device (1071); Fire (1245); Melted (1385)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/04/2021
Event Type  malfunction  
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 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.
 
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Brand NameTABLO X HEMODIALYSIS SYSTEM
Type of DeviceDIALYZER, 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
6692318235
MDR Report Key12425209
MDR Text Key269876909
Report Number3010355846-2021-00070
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K190793
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 09/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberPN-0006000
Device Catalogue NumberPN-0003000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Distributor Facility Aware Date08/05/2021
Event Location No Information
Date Manufacturer Received08/05/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/04/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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