RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
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Model Number V60 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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Date of event: (b)(6).Date of report: 21aug2019.The customer reported replacing the pm board and the problem went away for a while then returned.The customer then swapped the gui with another unit and the problem followed.The product support engineer (pse) advised the customer to replace the power switch over lay.The pse provided part number.This mdr has been reassessed as reportable after a request from the fda on march 1, 2019 to review complaints from 29 nov 2017 to 29 nov 2018.As this has been reassessed, it will appear to be a late mdr.
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Event Description
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The customer reports that the unit gives an (1105) light emitting diode (led) error code.The customer reported that the device was in clinical use at the time the issue was found; however, there was no patient or user harm.
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Search Alerts/Recalls
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