RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
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Model Number V60 |
Device Problems
Failure to Calibrate (2440); Operating System Becomes Nonfunctional (2996)
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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: 13jul2020.
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Event Description
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The customer reported the touchscreen was not responding.The customer indicated the touchscreen was not functioning, and was unable to calibrate.The field service engineer (fse) visited the customer site and confirmed the touchscreen is at fault and not the front bezel.The fse returned to the site with the touchscreen.The device did not have patient involvement at the time the issue was discovered, therefore, there was no patient or user harm reported.The fse replaced the touch screen, performances verified and safety tested successful corrective maintenance visit with reported problem.The fse confirmed and corrected reported problem.The device is now within the manufacturer¿s specification.
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Manufacturer Narrative
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G4: 15jul2020.B4: 16jul2020.The customer reported touchscreen failure.The field service engineer (fse) visited the customer site and confirmed the touchscreen failure with no display.The fse returned to site with touchscreen 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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