ST. JUDE MEDICAL WORKMATE CLARIS EP-4 CARDIAC STIMULATOR; COMPUTER, DIAGNOSTIC, PROGRAMMABLE
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Model Number H403023 |
Device Problem
Communication or Transmission Problem (2896)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/06/2021 |
Event Type
malfunction
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Event Description
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During the procedure, the ep-4 would not communicate with the system and the procedure had to be cancelled.There were no adverse consequences to the patient.
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Manufacturer Narrative
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One workmate¿ claris¿ ep-4¿ cardiac stimulator was received into the lab for analysis.Visual inspection of the returned product confirmed all input and output connectors are free of physical damage and all labeling is legible and correctly oriented.All mounting hardware was secured, and all socketed ic (integrated circuit) components were fully seated.Ac power was applied to the ep-4 stimulator which successfully executed the power on self-test.Preliminary voltage measurements confirmed system voltages to be within the specified limits.The returned cardiac stimulator was then subjected to and passed an extended pacing test without issue.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 root cause of the field reported event cannot be conclusively determined as no abnormalities were identified.The returned product successfully passed an extended pacing test without issue.
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