FDA Adverse Event
Malfunction
Summary report: N
WM CLARIS CPU
MDR report key: 11850420
·
Received May 19, 2021
Report
- Report Number
- 2184149-2021-00171
- Event Type
- Malfunction
- Date Received
- May 19, 2021
- Date of Event
- April 28, 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
- TX, 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, THERE WAS NO PACING OUTPUT. THERE WERE ADDITIONALLY ANOMALIES ENCOUNTERED IN SOFTWARE VERSION 1.2. THE DEVICE WAS POWER CYCLED AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE DEVICE WAS RETAINED BY THE CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 744016 | WM CLARIS CPU | COMPUTER, DIAGNOSTIC, PROGRAMMABLE | DQK | ST. JUDE MEDICAL, INC. | H700977 | 6809129 | 05415067009777 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |