RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
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Model Number V60 |
Device Problem
Therapeutic or Diagnostic Output Failure (3023)
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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) 2020.Date of report: 20mar2020.
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Event Description
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It was reported that the ventilators touch screen was not working.Reportedly, the unit locks up during the touch screen calibration.There was no patient involvement.
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Manufacturer Narrative
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B4: 24jul2020.G4: 23jul2020.H10: a touch screen assembly was returned for analysis.A visual inspection of the returned component was performed, no notable conditions were found.An investigation was performed and the product analysis technician reported that the root cause was due to the ul_lr and ur_ll resistance were out of specification and resistance ratio ul_lr/ ur_ll were out of specification.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: 29apr2020.B4: 05may2020.The service engineer (se) inspected the device and confirmed the reported issue.The se found that the screen was not working correctly in areas that are pressed and failed calibration.The se replaced the touchscreen and user interface board to address the reported issue.The unit was checked overall, 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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Search Alerts/Recalls
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