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 Consequences Or Impact To Patient (2199)
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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: 27aug2019.The customer is using products not tested and validated to be used on the v60.Bacteria filter: hudson rci bacterial/viral filter.Teleflex circuit: hudson rci adult conchasmart noninvasive breathing circuit with conchasmart column.Teleflex heater: hudson rci neptune philips clinical specialist informed cu the hudson heated circuit has too much resistance and is not approved for the v60.Only the f&p 25 mm circuit for heated wire is approved at this time.No parts were returned for failure investigation; therefore, the root cause at the component level could not be determined.
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Event Description
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The customer reported a few units that were not going in to standby.The device was in use at the time of the event; however, there was no patient harm.
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Search Alerts/Recalls
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