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Model Number V60 |
Device Problem
Energy Output Problem (1431)
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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: 22dec2020.
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Event Description
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It was reported to philips that the device had a power failure.The device was reported as being in use at the time of the event on a patient.The initial reporter confirmed that there was no adverse patient impact.
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Manufacturer Narrative
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G4:22feb2021; b4:23feb2021; h11:g5:k102985.H10: philips field service engineer (fse) was dispatched to the customer site and it was determined that the central processing unit printed circuit board assembly (cpu pcba) needed to be replaced to return the device to working condition.The fse replaced cpu pcba to resolve the issue and bring the device back to functionality.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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G4:24feb2021.B4:24feb2021.The device was reported to have been in testing while being set-up for use, there was no delay in therapy and no patient 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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