ST. JUDE MEDICAL, INC. WORKMATE¿ CLARIS¿ SYSTEM AMPLIFIER; PROGRAMMABLE DIAGNOSTIC COMPUTER
|
Back to Search Results |
|
Model Number H700169 |
Device Problem
Failure to Analyze Signal (1539)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 10/03/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
The results, method and conclusion codes along with investigation results will be provided in the final report.
|
|
Event Description
|
During the procedure, there were no egm or ecg signals displayed on the system and the error message "disconnect amp, 0 data packet" was displayed.The procedure ended up being cancelled.
|
|
Event Description
|
During the procedure, there were no egm or ecg signals displayed on the system and the error message "disconnect amp, 0 data packet" was displayed.The procedure ended up being cancelled and there were no adverse consequences to the patient.
|
|
Manufacturer Narrative
|
One workmate claris amplifier was received for evaluation.Visual inspection revealed the connectors, switches, and labels had no physical damage.All of the mounting hardware was secured.The returned workmate claris amplifier was powered on and successful communication was established with the test standard workmate claris computer.A basic signal acquisition/quality test which included the surface ecg, baseline, amplitude and stimulus switching were performed using a test media converter and confirmed that the returned amplifier performed within the factory specifications.The communication test was run for over 24 hours and no loss or drop in communication was observed.No noise artifact, ecg signal issue or packet error was observed.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The reported complaint of noise artifacts could not be confirmed as the workmate claris amplifier functioned as intended.
|
|
Search Alerts/Recalls
|
|
|