RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
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Model Number V60 |
Device Problem
Failure to Align (2522)
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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: 31aug2020.
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Event Description
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The customer reported a misalignment in the touchscreen.The service technician confirmed the touched position was misaligned in the touch screen, so the touchscreen was calibrated but the phenomenon did not improve.The device did not have patient involvement at the time the issue was discovered, therefore, there was no patient or user harm reported.The service technician replaced the touchscreen then confirmed the phenomenon was improved.No other abnormality was confirmed but the following parts were replaced as regulated by periodic maintenance procedure to prevent failure: oxygen inlet filter, air inlet filter and cooling fan filter.The unit was checked overall, cleaned, run in tested and functionally tested.
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Manufacturer Narrative
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G4: 13oct2020 b4: (b)(6) 2020 d4: udi:# (b)(4) a touchscreen assembly was returned for analysis.Visual inspection of the touchscreen assembly revealed no scratching or other damage.An investigation was performed and the customer complaint verified.Resistance measurement fail.After calibration, some buttons do not respond correctly.Root cause is failure of touchscreen assembly.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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