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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OUTSET MEDICAL, INC. TABLO(R) CARTRIDGE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
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OUTSET MEDICAL, INC. TABLO(R) CARTRIDGE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE Back to Search Results
Model Number PN-0005643
Device Problem Failure of Device to Self-Test (2937)
Patient Problem Insufficient Information (4580)
Event Date 09/13/2022
Event Type  malfunction  
Event Description
This is about a defective tablo cartridge while priming it with the tablo hemodialysis system.The machine keeps alarming self-failure 3x.First alarm, we checked all lines are locked and secured.Machined alarmed again.Rechecked and run the machine again.3rd alarm came and machine prompt to change the cartridge or end of treatment.We change the cartridge and the machine run normal again.
 
Event Description
This is about a defective tablo cartridge while priming it with the tablo hemodialysis system.The machine keeps alarming self-failure 3x.First alarm, we checked all lines are locked and secured.Machined alarmed again.Rechecked and run the machine again.3rd alarm came and machine prompt to change the cartridge or end of treatment.We change the cartridge and the machine run normal again.
 
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Brand Name
TABLO(R) CARTRIDGE
Type of Device
SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
Manufacturer (Section D)
OUTSET MEDICAL, INC.
3052 orchard drive
san jose CA 95134
MDR Report Key15592692
MDR Text Key301735131
Report Number15592692
Device Sequence Number1
Product Code FJK
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberPN-0005643
Device Catalogue NumberPN-0004220
Device Lot NumberD2206121
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/22/2022
Event Location Hospital
Date Report to Manufacturer10/12/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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