RESPIRONICS, INC. RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
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Model Number V60 V60PLUS VENTILATOR |
Device Problem
Increase in Pressure (1491)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/30/2023 |
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 device is getting a high-pressure alarm.It was reported there was no patient involvement at the time the issue was discovered.The customer evaluated the device with the assistance of the remote service engineer (rse) and confirmed the reported problem.The customer states that the device was turned into the biomed shop with high pressure alarm.The customer powered unit on in service mode and was unable to find any error in event log, then he powered on the device in normal operational mode, found that high inspiratory pressure alarm is set to only 6.The customer will inform staff about alarm setting and call back if further assistance is needed.The customer adjusted the alarm setting and the alarm went away.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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