ST. JUDE MEDICAL, INC. EP-WORKMATE¿ EP-4¿ CARDIAC STIMULATOR, 4 CHANNEL; COMPUTER, DIAGNOSTIC, PROGRAMMABLE
|
Back to Search Results |
|
Model Number 09-1527-0000 |
Device Problem
Communication or Transmission Problem (2896)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 11/25/2019 |
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, the ep-4 stimulator would not communicate with the workmate system.The stimulator was directly connected to the workstation with a serial cable.The stimulator settings were checked and it was selected under ¿stimulator¿.Replacing the serial cable and restarting the system did not resolve the issue.The procedure was cancelled and there were no adverse patient consequences.
|
|
Manufacturer Narrative
|
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 abbott specifications and procedures.Based on the information received, the cause of the reported incident could not be conclusively determined.
|
|
Search Alerts/Recalls
|
|
|