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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: 06oct2020.
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Event Description
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The customer reported display issue.There was no patient involvement.
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Manufacturer Narrative
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G4:22apr2021; b4:26apr2021.The customer reported display flickering issue.The system was evaluated and the issue was confirmed.The field service engineer (fse) replaced the front bezel to address the reported issue.The unit passed all testing.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: (b)(6) 2021.B4: (b)(6) 2021.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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Per the gfe response, it was reported that the issue was identified when being placed on a patient.The issue occurred prior to placing the unit on the patient, and there was delay of needing to go get another machine.
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Search Alerts/Recalls
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