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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: 30oct2020.
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Event Description
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The customer reported an alarm light emitting diode (led) failure.The unit was in clinical use at the time the reported issue was discovered; however, there was no harm to the patient or the user.
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Manufacturer Narrative
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G4:09apr2021.B4:19apr2021.The unit was not in clinical use at the time the reported issue was discovered.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.The device was evaluated remotely by a remote service engineer (rse).The rse suggested to repair the power switch overlay per service manual.The customer was provided with the part id for the power switch.Multiple good faith efforts were made to obtain information regarding device evaluation, repair, and operational status with no response from the reporter and therefore cannot be determined.If additional information is later obtained, a supplemental report will be submitted.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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