ST. JUDE MEDICAL, INC. ENSITE X EP SYSTEM AMPLIFIER; COMPUTER, DIAGNOSTIC, PROGRAMMABLE
|
Back to Search Results |
|
Model Number ENSITE-AMP-02 |
Device Problem
Failure of Device to Self-Test (2937)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 04/21/2023 |
Event Type
malfunction
|
Event Description
|
During preparation for an atrial tachycardia procedure, with the patient prepped, the ensite x amplifier did not pass self test and the case was cancelled.The initial single beep was heard after turning on the amplifier.However once the pc was turned on and attempted to communicate with the amplifier, three beeps occurred and the light at the front of the amp flashed red.An amplifier hardware error notification occurred on the dws.Troubleshooting involved turning off both the dws and ensite x amplifier, the power cables were removed and reinserted before turning on the dws and amplifier.This did not resolve the issue and the case was cancelled.
|
|
Manufacturer Narrative
|
One ensite x amplifier was received for evaluation.The amplifier was powered on and then the amplifier booted to a solid green ¿ready¿ light emitting diode (led) status.This indicated the amplifier passed the power-on-self-test (post) and then successfully communicated with the test station tracker software.The amplifier was connected to a field frame, wet lab, patient reference sensors (prs-a single, prs-p triple), surflink, 10 ecg lead cable set, and ecg simulator.The test amplifier was placed on a power relay, 5 minutes-on, 5 minutes-off.No anomalies were noted during the evaluation.The device was left on overnight and no observed loss of communications or post conditions were observed.Evaluation testing was successful.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the reported event were identified.Based on the information provided to abbott and the investigation performed, the reported self-test issue and subsequent cancellation remains unknown.
|
|
Search Alerts/Recalls
|
|
|