Model Number 2090 |
Device Problems
Device Difficult to Program or Calibrate (1496); Component Missing (2306); Failure to Calibrate (2440); Inadequate User Interface (2958)
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Patient Problem
No Patient Involvement (2645)
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Event Date 08/06/2018 |
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 cursor on the display screen of the programmer did not align with the stylus; the stylus was changed and software calibration was performed without success.It was also noted that the programmer was missing screws.The programmer is expected to be returned for repair.There was no patient involvement.
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Manufacturer Narrative
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Product analysis: analysis was able to confirm the reported stylus and cursor misalignment and the missing screws.Analysis also noted that the programmer was missing the stylus.A stylus was added and the connection between the printed circuit board (pcb) and the overlay was cleaned and reseated and the stylus was successfully calibrated.The hard drive was reconfigured, and the software was reloaded and updated.The device passed final functional and system tests.No other anomalies were found.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 further reported that the programmer was returned for repair.
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Search Alerts/Recalls
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