FDA Adverse Event
Malfunction
Summary report: N
RADIANALYZER¿ XPRESS¿
MDR report key: 7041214
·
Received November 17, 2017
Report
- Report Number
- 2184149-2017-00055
- Event Type
- Malfunction
- Date Received
- November 17, 2017
- Date of Event
- November 9, 2017
- Report Date
- January 19, 2018
- Manufacturer
- ST. JUDE MEDICAL, INC.
- Product Code
- DQK
- PMA / PMN Number
- K092105
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
PRODUCT EVALUATION: BASED ON THE INFORMATION PROVIDED TO ABBOTT AND THE INVESTIGATION PERFORMED, ROOT CAUSE OF THE FIELD REPORTED EVENT CITING A THERMAL EVENT IN THE POWER SUPPLY WAS SUCCESSFULLY ISOLATED TO A DAMAGED RESISTOR AT THE R9 LOCATION OF THE PRINTED CIRCUIT ASSEMBLY.
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION REVEALED THE INITIAL MDR FOR THIS EVENT WAS REPORTED UNDER THE INCORRECT MFR REPORT # AND MANUFACTURING SITE. THE CORRECT MFR NUMBER IS 8030904.
Description of Event or Problem · 1
WHEN THE RADIANALYZER XPRESS MONITOR WAS TURNED ON, AN ELECTRICAL SPARK AND SMOKE FROM THE POWER SUPPLY WAS REPORTED. NO PATIENT WAS INVOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 820951 | RADIANALYZER¿ XPRESS¿ | COMPUTER, DIAGNOSTIC, PROGRAMMABLE; COMPUTER, BLOOD-PRESSURE | DQK | ST. JUDE MEDICAL, INC. | C12711 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |