Model Number ORCHESTRA PLUS |
Device Problems
Operating System Becomes Nonfunctional (2996); Operating System Version or Upgrade Problem (2997)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/16/2015 |
Event Type
malfunction
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Event Description
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Reportedly, on (b)(6) 2015, smartview version 2.44 was not displayed on the printing ticket.The programmer was powered off properly afterwards.On (b)(6) 2015, it was not possible to interrogate a pacemaker and an error message was displayed.There were no patient files visible on the programmer screen and the programmer could not be used anymore.Preliminary analysis showed that the reported behavior was due to a hardware component failure.The subject programmer was returned for repair.
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Event Description
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Reportedly, on (b)(6) 2015, smartview version 2.44 was not displayed on the printing ticket.The programmer was powered off properly afterwards.On (b)(6) 2015, it was not possible to interrogate a pacemaker and an error message was displayed.There were no patient files visible on the programmer screen and the programmer could not be used anymore.Preliminary analysis showed that the reported behavior was due to a hardware component failure.The subject programmer was returned for repair.
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Manufacturer Narrative
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Please refer to the attached analysis report.
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Search Alerts/Recalls
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