RESPIRONICS, INC. RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
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Model Number V60 V60PLUS VENTILATOR |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/23/2024 |
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's moisture levels were not rising.The device was in clinical use when the issue occurred.No patient or user harm reported.The investigation is ongoing.
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Manufacturer Narrative
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Insufficient information is available to determine the resolution of the event.During follow up with the key market, the responder reported that multiple attempts were performed to contact the customer; however, the customer did not answer.The key market responder reported that no further investigating could be performed.As a result, 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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Search Alerts/Recalls
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