RESPIRONICS, INC. RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
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Model Number V60 V60PLUS VENTILATOR |
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 10/25/2023 |
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 pressure line sensor failed.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 discovered the error, the proximal pressure is not measured, and pressure-related alarms are compromised, in the event logs.The rse then reviewed the service manual and advised the customer that the replacement of the solenoid valves should be performed to resolve the issue.The rse provided the customer with the part number of the solenoid valves to order and replace.The investigation is ongoing.
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Manufacturer Narrative
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The customer replaced the solenoid valve to resolve the reported issue.The device passed the required performance verification tests per philips standards and was returned to service.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.
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