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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: 17jun2020.
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Event Description
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The manufacturer's field service engineer reported a ventilator that failed electrical safety and leak testing.There was no patient involvement.
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Manufacturer Narrative
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G4: 21oct2020 b4: (b)(6) 2020 the device was not in use at the time of the event.This issue occurred during testing.The customer requested the device be sent to the philips bench repair for evaluation and repairs.The philips bench technician evaluated the device and could not duplicate the reported complaint.The bench technician performed many high pressure and system leak tests and all passed.The bench technician recommended the customer check oxygen hoses at site.The bench technician also performed the electrical safety testing and the unit passes.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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G4:05feb2021.B4:08feb2021.A power cord (3 wire, rt angle, na, 10a) was returned for evaluation.Visual inspection of power cord revealed no evidence of damage or contamination.A failure investigation (fi) technician installed the power cord into a fi ventilator to duplicate the reported issue.The power cord resistance was measured between each connectors and flexing the cable during the measurement.The power cord ground resistance was found to be out of specification.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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