FDA Adverse Event
Injury
Summary report: N
EP-WORKMATE SCU-SIGNAL CONDITIONING UNIT (AMPLIFIER), 120 CHANNEL
MDR report key: 10508714
·
Received September 9, 2020
Report
- Report Number
- 2184149-2020-00132
- Event Type
- Injury
- Date Received
- September 9, 2020
- Date of Event
- August 28, 2020
- Report Date
- September 9, 2020
- Manufacturer
- ST. JUDE MEDICAL, INC.
- Product Code
- DQK
- UDI-DI
- 05415067003119
- PMA / PMN Number
- K092810
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE REVIEW DETERMINED THE PROCESS WAS PERFORMED AND COMPLETED IN ACCORDANCE WITH ABT SPECIFICATIONS AND PROCEDURES. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE DETERMINED.
Description of Event or Problem · 1
DURING THE PROCEDURE, THE AMPLIFIER WOULD NOT BOOT UP AND ONE SINGLE CONTINUOUS BEEP WAS HEARD AND THE PROCEDURE WAS CANCELLED. THE AMPLIFIER WAS REBOOTED SEVERAL TIMES, BUT THE ISSUE REMAINED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT DUE TO THE CANCELLATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 974797 | EP-WORKMATE SCU-SIGNAL CONDITIONING UNIT (AMPLIFIER), 120 CHANNEL | COMPUTER, DIAGNOSTIC, PROGRAMMABLE | DQK | ST. JUDE MEDICAL, INC. | 09-1463-0120 | 5708101 | 05415067003119 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |