RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
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Model Number V60 |
Device Problems
Device Displays Incorrect Message (2591); Computer Operating System Problem (2898)
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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: 09oct2020.
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Event Description
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The customer reported that the unit logged a backup alarm failed error.The customer contacted product support and was advised to replace the cpu board.They discussed the reloading of the s/n, power on hrs, and options.The customer decided to call back for option codes.The customer called back for support getting terra term set up on new laptop.They were instructed to download rev 4.79 and informed where to access that.Reviewed manual procedures for download, installation and set up.The customer reported that the unit was not in use on a patient.
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Manufacturer Narrative
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G4: 01oct2020 b4: (b)(6) 2020.The biomed replaced the central processing unit (cpu) board to address the reported problem.Customer is reporting the v60 option code restoration was successful.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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