RESPIRONICS CALIFORNIA, INC BIPAP FOCUS NONINVASIVE VENTILATOR SYSTEM; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
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Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Communication or Transmission Problem (2896)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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Date of event: (b)(6) 2019.The manufacturer¿s international service technician could not confirm the reported issue.The customer kept the unit running overnight and no errors appeared at all.The unit successfully passed the required performance verification test.The determination could not be made that the device failed to meet specifications.The device was not being used for treatment when the reported event occurred, and there is not a relationship of the device to the reported problem.The part was not returned to failure investigation.
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Event Description
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The customer reported an inter processor communications error, test failure, and settings test failure.There was no patient involvement.
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Search Alerts/Recalls
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