RESPIRONICS, INC. V60 V60PLUS VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
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Model Number V60 V60PLUS VENTILATOR |
Device Problem
Pressure Problem (3012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/04/2024 |
Event Type
malfunction
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Manufacturer Narrative
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E1: (b)(6).
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Event Description
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Philips received a complaint from the customer, reporting that the v60 ventilator had a pressure issue.It was unknown how the issue was found.No patient or user harm reported.A philips remote service engineer (rse) noted that the customer's v60 ventilator had a pressure issue.The customer was provided with a proposal to have the device evaluated/repaired.
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Manufacturer Narrative
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H10: insufficient information is available to determine the resolution of the event.The customer was provided with a proposal for repair; however, the proposal expired, and the record was closed.No further actions were performed by philips.No further details could be documented 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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