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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: 03nov2020.
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Event Description
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The customer reported a check vent aux alarm supply failure.The device was in clinical use at the time of the issue however no patient harm was reported.The field service engineer advised the customer the motor controller board, power management board, power supply, or cpu may be faulty and provided part numbers.The fse advised the caller that if the customer is unable to reproduce the issue, it would be advisable to replace the motor controller board as a precaution as it is first on the list of likely causes.
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Manufacturer Narrative
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G4:10feb2021.B4:11feb2021.The customer replaced the motor controller board and the issue was resolved.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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G4:25mar2021.B4:07apr2021.The customer clarified that the device was not yet connected to the patient but was being set up for therapy initiation when the issue was discovered, so the staff decided to utilize a different ventilator.There was no patient involvement or harm.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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