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Model Number V60 |
Device Problem
Therapeutic or Diagnostic Output Failure (3023)
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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: 23nov2020.
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Event Description
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It was reported that the ventilator had a check vent primary alarm failed error.The ventilator was being used on a patient at the time of the reported event; however, there was no patient harm reported.
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Manufacturer Narrative
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G4: 18dec2020.B4: 07jan2021.The service engineer (se) inspected the device and confirmed the reported issue.The se replaced the speaker assembly to address the reported issue.The unit was checked overall, run in tested, cleaned, functionally tested and no abnormality was 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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G4:08apr2021.B4:12apr2021.Two speakers were returned for analysis.A visual inspection of the returned component was performed, no notable conditions were found.An investigation was performed and the product analysis technician reported that the root cause was due to an electrical open in the speaker.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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