RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
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Model Number V60 |
Device Problems
Component Missing (2306); Failure to Calibrate (2440)
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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: 01/08/2020.
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Event Description
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During periodic maintenance, the manufacturer's authorized service representative discovered the touchscreen calibration failed.It was also noted that the rubber boots were missing.There was no patient involvement.The manufacturer's authorized service representative confirmed the touchscreen would not calibrate.The manufacturer's authorized service representative replaced the touchscreen and rubber boots.Overall checks, cleaning, and a function test were completed.The software was checked as version 2.30.
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Manufacturer Narrative
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G4: 01aug2020 b4: (b)(6) 2020 touchscreen assembly was returned to failure investigation (fi) for evaluation.Visual inspection of the touchscreen assembly revealed no evidence of damage or contamination.Fi technician verified the assembly resistance measurements were not in specifications.Customer complaint verified.The resistance measurements of the touchscreen assembly were out of specifications.Fault are found on this returned 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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