RESPIRONICS, INC. RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
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Model Number V60 |
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 01/23/2023 |
Event Type
malfunction
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Event Description
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Philips received a complaint on the v60 ventilator, indicating that the unit had error message: high flow pressure safety trigger due to cannula use.It is unknown if the device was in clinical use at the time the issue was discovered, however, there was no patient or user harm reported.
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Manufacturer Narrative
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The customer called in to report that the high flow pressure safety was triggered due to cannula use.The rse informed the customer that they did not have the high flow therapy option (since the high flow therapy option was not purchased), and that they were not on the list for field change order (fco).The case was then cancelled.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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