RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
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Model Number V60 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Displays Incorrect Message (2591)
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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) 2020.Date of report: 09mar2020.
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Event Description
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It was reported that the unit's "breaths per minute" was not correct.The device was in use at the time of the event; however, there was no patient harm.The manufacturer's field service engineer (fse) performed troubleshooting and was unable to confirm the reported issue.The fse did note that the unit declared a low leak co2 rebreathing risk error.When the fse inspected the unit's blower assembly and gas delivery system (gds), there was an unknown yellow liquid inside.The fse replaced the gds and blower assembly and the issue was resolved.
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Manufacturer Narrative
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G4: 25jul2020.B4: 28jul2020.Gas delivery system (gds) assembly and blower motor (blower motor assembly) were returned for analysis.Visual inspection revealed the revealed no anomalies.Failure investigation (fi) technician installed the gds assembly into a fi ventilator to duplicate the reported issue.During the unit testing the air flow sensor failed, the reported issue was duplicated, and the fi technician identified that a component in reference designation u1 on the air flow sensor out of specification.There was no fault was found with the blower unit.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
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