Model Number 229047 |
Device Problems
Device Displays Incorrect Message (2591); Computer Operating System Problem (2898); Data Problem (3196); Application Program Freezes, Becomes Nonfunctional (4031)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/06/2018 |
Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that the user attempted to print a report, and the analyzer software froze up and a message was displayed stating that the print queue needed to be deleted.Pacing mode was unable to be exited, and the user cycled the programmer's power.It was further reported that upon restart, the programmer was unable to complete device interrogation.It was noted that this was accompanied by a message indicating the print queue was full.It was further reported that the programmer failed to complete a software update.It was noted that this failure was accompanied by an error code.The programmer and analyzer were returned for service.No patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Product analysis: no issues were identified with the analyzer.The lock-up behavior was identified as an issue with the associated programmer.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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