FDA Adverse Event
Malfunction
Summary report: N
WM CLARIS CPU
MDR report key: 11850580
·
Received May 19, 2021
Report
- Report Number
- 2184149-2021-00169
- Event Type
- Malfunction
- Date Received
- May 19, 2021
- Date of Event
- April 14, 2021
- Report Date
- November 19, 2021
- Manufacturer
- ST. JUDE MEDICAL
- Product Code
- DQK
- UDI-DI
- 05415067009777
- PMA / PMN Number
- K151911
- Removal / Correction Number
- 2184149-05/05/21-001-R
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL DATA: G3, H2, H10 CORRECTED DATA: H6
Additional Manufacturer Narrative · 1
THE INVESTIGATION REVEALED THAT AFTER THE WORKMATE CLARIS V.1.2 SOFTWARE UPGRADE, THE WORKMATE CLARIS DWS SCREEN TURNS BLACK/BLANK AND THE USER NEEDS TO REBOOT THE SYSTEM TO REGAIN FUNCTIONALITY.
Description of Event or Problem · 1
DURING THE PROCEDURE, THE DISPLAY SCREENS WENT BLACK. THE DEVICE WAS REBOOTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 743688 | WM CLARIS CPU | COMPUTER, DIAGNOSTIC, PROGRAMMABLE | DQK | ST. JUDE MEDICAL | H700977 | 7644445 | 05415067009777 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |