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Model Number V60 |
Device Problems
Defective Alarm (1014); Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Date of event: (b)(6) 2020.Date of report: 29oct2020.
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Event Description
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The customer reported that the unit failed with backup alarm test failure.The customer contacted product support and requested for service repair.The customer reported that the unit was not in use on a patient.
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Manufacturer Narrative
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G4:22oct2020.B4:15dec2020.The bench service engineer could not replicate the fault.The central processing unit (cpu) board was replaced as a precaution.Set the sn, options, and total power-on hours.The service engineer performed full performance assurance (pa) testing and extended self-test.All tests passed successfully.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
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Manufacturer Narrative
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G4:06feb2021; b4:15feb2021.Failure analysis on the returned cpu board it was determined that it was ls1 failure.Ls1's built without a date code could be subject to cold joints within ls1 that can result in ls1 failing to sound.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
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Search Alerts/Recalls
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