RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
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Model Number V60 |
Device Problem
Failure to Read Input Signal (1581)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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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: 16sep2020.
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Event Description
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It was reported to philips that the device had a touchscreen malfunction.The device was not being used on a patient at the time of the event.There was no patient or user harm reported.
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Manufacturer Narrative
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G4: 11nov2020.B4: 11nov2020.A philips field service engineer (fse) was dispatched to the customer site and it was determined that the touchscreen needed to be replaced to return the device to working condition.The fse replaced the touchscreen.The device passed performance verification testing and was placed back into service.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: 13nov2020.B4: 13nov2020.H11: a philips field service engineer (fse) was dispatched to the customer site and it was determined that the front bezel needed to be replaced to return the device to working condition.The fse replaced the front bezel.The device passed performance verification testing and was placed back into service.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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