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Model Number V60 |
Device Problems
Image Display Error/Artifact (1304); Device Displays Incorrect Message (2591)
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Patient Problem
Insufficient Information (4580)
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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: 09sep2020.
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Event Description
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It was reported to philips that a nurse found "pressure regulation high" alarm occurrence while the device was in use on the patient.The screen turned dark afterwards and the device stopped operating.The device was in clinical use at the time of the event.The nurse reported it to an medical engineer and the device was replaced with the same model (v60).There was no medical intervention reported.The device was evaluated by a philips service technician who confirmed that the data acquisition (da) board required replacement to resolve the issue.
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Manufacturer Narrative
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G4:17dec2020.B4:18dec2020.The data acquisition (da) pcba was returned to the manufacturer for analysis.Visual inspection of the data acquisition (da) pcba revealed no evidence of damage or contamination.The failure investigation (fi) technician installed the data acquisition (da) pcba into a fi ventilator to duplicate the reported issue.The returned data acquisition (da) pcba was tested and no failures were identified.The customer complaint was not duplicated and could not be confirmed.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: 24nov2020, b4: 24nov2020.The device was evaluated by an international service technician who could not confirm the reported issue during operational testing, but noted an error associated with pressure regulation high in the event log.The service technician replaced the data acquisition board and the device passed all functional testing and was returned to service.Based on information provided and/or service performed, the customers alleged malfunction was confirmed.The device was being used for treatment when the reported event occurred.No parts were returned for failure investigation; therefore, the root cause at the component level could not be determined.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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