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 11/14/2023 |
Event Type
malfunction
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Event Description
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Philips received a complaint from the customer, reporting that the v60 ventilator displayed an alarm, indicating that the oxygen supply pressure was too high.The device was in clinical use when the issue occurred, and the patient was moved to a different ventilator.No patient or user harm reported.The customer reported that the oxygen supply pressure was checked, and was within normal range.Investigation is ongoing.
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Manufacturer Narrative
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Reporting institution phone number: (b)(6).Reporter phone number: (b)(6).
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Manufacturer Narrative
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H10: insufficient information is available to determine the resolution of the event.Multiple good faith efforts (gfe) were performed on (b)(6) 2023, and (b)(6) 2024 for further details regarding the event; however, no response was provided.No further details could be obtained regarding the event, and it could not be determined if the customer's issue was resolved or if the device had been repaired.No parts were returned for failure investigation.In the event that parts are returned or if new information is provided, the complaint will be reopened to update the investigation.
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