FDA Adverse Event
Malfunction
Summary report: N
WM CLARIS CPU
MDR report key: 11855202
·
Received May 20, 2021
Report
- Report Number
- 2184149-2021-00176
- Event Type
- Malfunction
- Date Received
- May 20, 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
- MO, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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
POST NETWORK CONFIGURATION CLARIS 1.2 WOULD NOT BOOT TO APPLICATION. THE COMPUTER WAS TAKEN OFF THE DOMAIN TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED. THE DEVICE WAS RETAINED THE CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 754799 | WM CLARIS CPU | COMPUTER, DIAGNOSTIC, PROGRAMMABLE | DQK | ST. JUDE MEDICAL, INC. | H700977 | 7326257 | 05415067009777 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |