FDA Adverse Event
Malfunction
Summary report: N
WM CLARIS CPU
MDR report key: 11854575
·
Received May 20, 2021
Report
- Report Number
- 2184149-2021-00165
- Event Type
- Malfunction
- Date Received
- May 20, 2021
- Date of Event
- March 30, 2021
- Report Date
- November 19, 2021
- Manufacturer
- ST. JUDE MEDICAL, INC.
- 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
- MI, 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 (B)(4) 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, WHILE PACING, THE CLARIS APP CLOSED AND EXITED TO THE DESKTOP. THE COMPUTER HAD BEEN UPGRADED TO (B)(4) SOFTWARE, CLARIS 1.2, THE PREVIOUS NIGHT. THE ISSUE WAS RESOLVED BY REBOOTING THE SYSTEM. THE CASE WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 754772 | WM CLARIS CPU | COMPUTER, DIAGNOSTIC, PROGRAMMABLE | DQK | ST. JUDE MEDICAL, INC. | H700977 | 5483048 | 05415067009777 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |