Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
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
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 to Deliver (2338)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/13/2022
Event Type  malfunction  
Event Description
Tech reports that a tablo machine had an error pop up saying "drip chamber level failure".He reports that he followed the instructions given to us by our outset representative and cleaned the tablo sensors with a wet paper towel before putting the cartridge in.He tried the setup twice with the same cartridge and got the same error both times, so he changed to a different cartridge.The second cartridge worked and the set up was able to be completed at that time.
 
Event Description
Tech reports that a tablo machine had an error pop up saying "drip chamber level failure".He reports that he followed the instructions given to us by our outset representative and cleaned the tablo sensors with a wet paper towel before putting the cartridge in.He tried the setup twice with the same cartridge and got the same error both times, so he changed to a different cartridge.The second cartridge worked and the set up was able to be completed at that time.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key15731190
MDR Text Key303051038
Report Number15731190
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 10/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberPN-0005643
Device Catalogue NumberPN-0004220
Device Lot NumberK22D083
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/21/2022
Event Location Hospital
Date Report to Manufacturer11/04/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-