RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
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Model Number V60 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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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: 06may2020.
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Event Description
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The customer reported while doing preventative maintenance performance verification testing that the ventilator failed pressure testing.There was no patient involvement.
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Manufacturer Narrative
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G4: 06aug2020.B4: 07aug2020.The customer replaced the power management printed circuit board assembly and the issue was resolved.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: 15jul2020 b4: (b)(6) 2020 the customer attempted to repair the unit by installing a new central processing unit, however this did not resolve the problem.The following good faith efforts were made to contact the customer to obtain the resolution, however there was no response received.1.(b)(6) 2020 @ 12:06pm; emailed (b)(6) 2.(b)(6) 2020 @ 08.54pm; emailed (b)(6) 3.(b)(6) 2020 @ 12:52pm; emailed (b)(6) 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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