RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
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Model Number V60 |
Device Problem
Failure of Device to Self-Test (2937)
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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) 2019.Date of report: 22april2019.A follow-up report will be submitted once the investigation has been complete.
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Event Description
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The customer reported that after the exhalation port was selected as "others", the exhalation port test did not occur.There was no patient involvement.Event date not specified, estimate used.
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Manufacturer Narrative
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Adverse event or product problem: correction "product problem".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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Date of report : 21jun2019, date rec¿d by mfr : 20jun2019.The manufacturer¿s international service technician confirmed the reported port test issue.The reported phenomenon occurred due to malfunction of airflow sensor.The manufacturer¿s international service technician replaced the airflow sensor to address the reported problem.The unit was checked overall, run in tested, cleaned and 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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Date rec¿d by mfr : 19jul2019, date of report : 05aug2019.During further investigation (fi), failure analysis on the returned gas delivery system (gds) revealed no evidence of damage or contamination.The gds assembly revealed a defective air flow sensor on the airflow sensor pcba that was found generating the erroneous airflow average air display reading.The defective air flow sensor pcba caused the airflow accuracy test to fail.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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Search Alerts/Recalls
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