RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
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Model Number V60 PLUS |
Device Problem
Defective Device (2588)
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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) 2021.12mar2021.
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Event Description
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It was reported that the ventilator displays a "peak flow alarms not reached" and a "patient disconnection" alarm suddenly.Then the ventilator stops randomly.The ventilator was being used on a patient at the time of the reported event; however, there was no patient harm reported.The customer was using an unapproved accessory (opti flow).The customer was provided with additional training on high flow therapy.
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