Model Number V60 V60PLUS VENTILATOR |
Device Problems
Device Alarm System (1012); No Flow (2991)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/16/2023 |
Event Type
malfunction
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Event Description
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Philips received a complaint by the customer on the v60 indicating that when turning the device on, it displayed a message of " not working" and does not ventilate.It was reported there was no patient involvement at the time the issue was discovered, it was discovered at turn on.The customer evaluated the device with the assistance of the remote service engineer (rse) and confirmed the reported problem.The rse dispatched a field service engineer (fse) for onsite repair.The investigation is ongoing.
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Manufacturer Narrative
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The customer evaluated the device with the assistance of the remote service engineer (rse) and confirmed that the device alarmed.Per further investigation it was clarified that there was an unknown alarm condition that was reported, and once the field service engineer (fse) was dispatched to the site for further evaluation and repair, it was confirmed that there was a 1102 primary alarm failed message.The fse replaced the motor control board and left speaker to resolve the reported issue.The device passed required performance verification tests per philips standards and was returned to service.Based on this clarification, h6 - device problem code has been updated.
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Manufacturer Narrative
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The device was in use on a patient at the time the reported issue was discovered; however, there was no harm to the patient or user.No medical intervention provided to the patient, nor a delay was noted.After further investigation by the field service engineer (fse) it was confirmed that the motor control board and left speaker will need to be replaced.The fse replaced motor control board and left speaker to resolve the reported issue.The device passed required performance verification tests per philips standards and was returned to service.The investigation concludes that no further action is required at this time.
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Manufacturer Narrative
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The removed motor control printed circuit board assembly (pcba) was returned to the product investigation lab (pi).The pil technician installed the motor control pcba into a pi ventilator to duplicate the reported issue.Visual inspection of the motor control pcba revealed no evidence of damage or contamination.The motor control pcba was tested, the failure was not confirmed.No fault found in the component under test.
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Search Alerts/Recalls
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