Model Number 201 |
Device Problems
Image Display Error/Artifact (1304); Difficult to Interrogate (1331)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/12/2016 |
Event Type
malfunction
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Event Description
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It was reported by a physician that a handheld programmer was giving him trouble upon interrogation.He stated that the screen would freeze on the device.Additional relevant information has not been received to-date.
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Event Description
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Follow-up from the physician provided that the screen freezes and that communication does not happen until the cable is moved around.
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Manufacturer Narrative
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Event description, corrected data: part of the event description information was inadvertently not provided in the initial report.Brand name, corrected data: the brand name of the suspect device was inadvertently provided incorrectly in the initial report.Type of device, corrected data: the type of device of the suspect device was inadvertently provided incorrectly in the initial report.Model #, corrected data: the model number of the suspect device was inadvertently provided incorrectly in the initial report.
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Event Description
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The physician reported that the screen would freeze and he often would need to move the wand cable for it to transmit, indicating the programming wand as the suspect device.
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Event Description
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Follow-up from the physician provided that communication errors occurred intermittently, but could be resolved with difficulty by manipulating the wand cable.However, sometimes during the communication the screens would freeze during the attempts to interrogate.
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Event Description
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The handheld and software were received by the manufacturer.Analysis is underway, but has not been completed to-date.
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Manufacturer Narrative
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It was inadvertently not provided on follow-up report #4 that the programming wand also had been received.
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Event Description
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The programming wand was received for analysis.Analysis was completed for the handheld and flashcard and wand.No anomalies associated with the handheld were noted during testing.The handheld performed according to functional specifications.No anomalies associated with flashcard software or databases were identified during analysis.The flashcard and software performed according to functional specifications.Analysis of the programming wand analysis showed the serial data cable produced communication errors and had intermittent conductors at the handle location.A known good bench serial data cable was substituted and all communications errors cleared.Continuity testing of the battery cable passed.After the serial data cable was substituted, the programming wand performed according to functional specifications.
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Search Alerts/Recalls
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