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: 21apr2020.
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Event Description
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The customer reported a test results error.There was no patient involvement.The manufacturer¿s international service technician evaluated the ventilator and ordered a power switch overlay, proximal kit, foot kits, top cover and battery.
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Manufacturer Narrative
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G4: 17jun2020.B4: 18jun2020.H11: the service technician ordered a proximal port not a proximal kit.H10: additional information was received that this ventilator used to be rented out to hospitals but it has been out of service for over 3 years.The service technician confirmed that the battery was being replaced due to its age, as it was around 5 or 6 years old and had never been replaced.Based on this information, the reported failures are unlikely to cause or contribute to death or serious injury; therefore, this complaint has been reassessed as a non-reportable event.The service technician reported that the repair was not approved and the device will not be repaired.No service was rendered.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: 30apr2020.B4: (b)(6)2020.The manufacturer¿s international service technician reported that during test and evaluation, the power switch overlay was found to be faulty.The service technician reported that the other parts need to be replaced due mechanical wear and cracks.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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