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 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) 2018.Date of report: 27aug2019.The manufacturer¿s international service technician confirmed the reported pressure issue.The manufacturer¿s international service technician replaced the data acquisition (da) pcba to address the reported problem.The unit was checked overall, run in tested, cleaned and functionally tested and no abnormality was confirmed.The customer returned data acquisition (da) board was tested and no failures were identified.The root cause of the reported issue could not be determined.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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During periodic maintenance, the manufacturer¿s international service technician discovered that the zero point specification was out of tolerance.There was no patient involvement.
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Search Alerts/Recalls
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