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Model Number V60 |
Device Problems
Loose or Intermittent Connection (1371); Pressure Problem (3012)
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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: 16oct2020.
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Event Description
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The customer contacted technical support (ts) stating that the unit had a pressure issue.There was no patient involvement.The reported issue was found during setup.No delay or intervention was reported.The customer, the biomed, evaluated the unit and found the data acquisition (daq) board was loose.The customer reseated the unit's daq board to resolve the reported issue.The unit was tested and passed.The unit returned to service.
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Manufacturer Narrative
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G4:25jan2021 and b4:25jan2021 h3: not returned to manufacturer.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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