RESPIRONICS, INC. RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
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Model Number V60 V60PLUS VENTILATOR |
Device Problem
Failure to Sense (1559)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/14/2024 |
Event Type
malfunction
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Event Description
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Philips received a complaint by the customer on the v60, indicating that there was a patient disconnect issue.It was reported that there was no patient involvement at the time the issue was discovered.The customer called technical support to report that there was a patient disconnect issue.Resolution and disposition are pending.
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Manufacturer Narrative
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E1: reporting institution name: (b)(6).Reporting address state: (b)(6).Reporting address postal: (b)(6).Reporting institution phone #: (b)(6).Reporter phone #: (b)(6).G1 contact office phone: (b)(6).
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Manufacturer Narrative
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The customer called technical support to report that there was a patient disconnect issue.Per good faith effort (gfe) response received on 20may2024, the authorized service provider (asp) stated that the issue was resolved after the nurse replaced the patient circuit.The device passed the required performance verification tests per philips standard 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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