RESPIRONICS, INC. RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
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Model Number V60 |
Device Problem
Device Sensing Problem (2917)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/06/2023 |
Event Type
malfunction
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Event Description
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Philips received a complaint from the customer on the v60 indicating that the standby button was not active, and that the device will not go into standby mode.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.The customer evaluated the device with the assistance of the remote service engineer (rse) and confirmed the reported problem.The rse performed a troubleshoot with the customer and confirmed the device was showing 15 for the air flow slpm when it should be -1 or 1.The rse then advised the customer that a replacement of the flow sensor assembly is recommended to resolve the issue.The rse provided the customer with the part number for the flow sensor assembly to order and replace.
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Manufacturer Narrative
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Multiple attempts have been made to try to obtain further information about this case but no response has been received from the customer.The complaint will be processed for closure.If additional information becomes available at a later date, the complaint will be reopened, and a supplemental report will be submitted.
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Search Alerts/Recalls
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