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 Problems
Dyspnea (1816); Hypoxia (1918)
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Event Date 02/14/2024 |
Event Type
malfunction
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Manufacturer Narrative
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E1: reporter phone #: (b)(6).G1 contact office phone: (b)(6).
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Event Description
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Philips received a complaint on the v60 ventilator, indicating that there was a pressure sensor autozero failed alarm.The device was reported to be in use at the time of the reported problem.No patient or user harm reported.The customer stated that the patient was admitted due to respiratory failure.The patient was placed on the v60 ventilator for non-invasive ventilation.After about 30 minutes of normal use, the customer reported a proximal pressure sensor autozero failure occurred.The v60 was immediately stopped, and the patient's oxygen saturation decreased to 92%.The customer replaced the v60 with another ventilator and the patient was able to use it normally.The patient's oxygen saturation returned to 100%.As the patient's oxygen concentration returned to 100%, and the device continues to provide ventilation even after a proximal pressure sensor autozero failure, this is not considered a potential cause of serious injury.The investigation is ongoing.
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Manufacturer Narrative
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H10: in a good faith effort (gfe) response from the authorized service provider (asp) received on 26apr2024, it was stated that the device repair was still pending, but the customer had chosen a 3rd party for repair of the device.As the customer chose a 3rd party for repair, no further work will be completed by philips to repair the device for this device issue.The asp also stated that the patient information was unknown.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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