Model Number GALI DF1 SONR CRT-D 2811 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Displays Incorrect Message (2591)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/04/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The device involved in this mdr report is not approved in the united states; however, it is similar to a device manufactured by microport crm that was cleared or approved by fda for marketing in the united states.
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Event Description
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Reportedly, the date/hour of tests are printed incorrectly, whereas they are correctly displayed on the programmer.
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Event Description
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Reportedly, the date/hour of tests are printed incorrectly, whereas they are correctly displayed on the programmer.Second occurrence of the problem on another device.
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Manufacturer Narrative
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Data analysis showed the raat and lvat start time values are not printed in the correct format.When printing raat or lvat start time, the printing value is ¿&xxat_1h¿ instead of ¿1:00¿ or ¿&xxat_2h¿ instead of ¿2:00¿.This issue occurs in direct print and in the report printing.- corrective actions of this software issue are currently being contemplated.
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Search Alerts/Recalls
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