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: 28jul2020.
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Event Description
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The v60 unit was sent to the international service center for routine periodic maintenance.There was no patient involvement.The manufacturer¿s international service technician during device servicing identified the touch screen had a misalignment between touch position and response position.Calibration was performed, but the issue was not fixed, so the touch screen was replaced then it was fixed.No other issues were identified.The device successfully passed performance verification testing.The device is ready to be sent back to the customer for patient use.
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Manufacturer Narrative
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G4:03dec2020.B4:05dec2020.Visual inspection of the returned defective touchscreen assembly revealed no evidence of damage or contamination.The touch screen assembly was installed into an failure investigation (fi) test ventilator in an attempt to duplicate the reported problem of touchscreen failure.The fi investigation determined that the ul_lr and ur_ll resistance were out of specification which caused the touchscreen to fail.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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