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Model Number V60 |
Device Problem
No Display/Image (1183)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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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: 15oct2020.
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Event Description
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The customer reported data does not display.The device did not have patient involvement at the time the issue was discovered, therefore, there was no patient or user harm reported.
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Manufacturer Narrative
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G4:15dec2020.B4:16dec2020.The service engineer clarified there was no issue with the display; the actual malfunction was tidal volume cannot show.The issue was determined to be due to a defective gas delivery system (gds).The customer declined the quote for service and has repaired the device on their own.It was reported that the device is back to normal.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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G4:03dec2020, b4:06dec2020.The engineer checked the machine and did not see any moisture but found a broken flow sensor.The user was provided with a quote but was rejected.No repair service performed.The customer repaired the device.No other information was provided.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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