FDA Adverse Event
Malfunction
Summary report: N
TABLO(R) CARTRIDGE
MDR report key: 15824944
·
Received November 18, 2022
Report
- Report Number
- 15824944
- Event Type
- Malfunction
- Date Received
- November 18, 2022
- Date of Event
- October 21, 2022
- Report Date
- October 26, 2022
- Manufacturer
- OUTSET MEDICAL, INC.
- Product Code
- FJK
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- UT
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
TABLO MACHINE FAILED THE SELF-TEST WITH TABLO CARTRIDGE (LOT #K22E103) DURING SETUP. SETUP WAS TAKEN DOWN. THE TECH GATHERED NEW SUPPLIES AND RE-SET THE MACHINE WITH THE NEW SUPPLIES. THE MACHINE PASSED THE SELF-TEST, AND WE WERE ABLE TO DO THE TREATMENT. THIS ISSUE HAPPENED A SECOND TIME LATER THE SAME DAY, SAME LOT NUMBER.
Description of Event or Problem · 0
TABLO MACHINE FAILED THE SELF-TEST WITH TABLO CARTRIDGE (LOT #K22E103) DURING SETUP. SETUP WAS TAKEN DOWN. THE TECH GATHERED NEW SUPPLIES AND RE-SET THE MACHINE WITH THE NEW SUPPLIES. THE MACHINE PASSED THE SELF-TEST, AND WE WERE ABLE TO DO THE TREATMENT. THIS ISSUE HAPPENED A SECOND TIME LATER THE SAME DAY, SAME LOT NUMBER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 229406 | TABLO(R) CARTRIDGE | SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE | FJK | OUTSET MEDICAL, INC. | PN-0005643 | K22E103 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |