RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
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Model Number V60 |
Device Problem
No Flow (2991)
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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) 2020.Date of report: 22apr2020.
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Event Description
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It was reported that while in use, the ventilator airflow ceased.The customer reported that the ventilator was under the continuous positive airway pressure (cpap) mode when a "proximal pressure line disconnect" alarm sounded.Reportedly, when a nurse checked the device, the flow had stopped running.The device then failed to start providing flow afterwards.A doctor switched the cpap mode to the spontaneous with timed backup (s/t) mode and the device was able to start providing flow.After that, the mode was returned to the cpap mode until a replacement device was able to continue providing flow.The patient was removed from the ventilator and placed on an alternate ventilator.The patient was not harmed or injured as a result of the reported event.The manufacturer¿s international service technician inspected the device and could not duplicate the reported issue.Visual inspection was performed and no abnormality was found and no error codes were found in the ventilator diagnostic logs.The service technician found that the blower needs to be replaced.
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Manufacturer Narrative
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G4: 15jun2020; b4: 16jun2020.The service technician reported that the reported issue was not duplicated and the reported issue could have been caused by an abnormality in the circuit side.The service technician reported the blower was replaced as part of periodic maintenance.The unit was checked overall, run in tested, cleaned, functionally tested and no abnormality was confirmed.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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Manufacturer Narrative
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G4: 18jun2020 b4: 18jun2020 b5: the patient was not placed on an alternate ventilator.The doctor was able to change the mode on the ventilator and able to start providing flow to the patient.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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