RESPIRONICS, INC. RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
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Model Number V60 |
Device Problem
Blocked Connection (2888)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/18/2023 |
Event Type
malfunction
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Manufacturer Narrative
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E1: reporting institution phone: (b)(6).Reporter phone number: (b)(6).
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Event Description
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Philips received a complaint from the customer on the v60 indicating that a 1201 "patient circuit occluded" alarm error occurred.The device was in use on a patient at the time the reported issue was discovered; however, there was no harm to the patient or user.Additionally, the device was swapped out for another ventilator.The investigation is ongoing.
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Manufacturer Narrative
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Per a good faith effort (gfe) response, the technician could not duplicate the 1201 error code, and no fault was found.No further information will be obtained.The investigation concludes that no further action is required at this time.If the decision is made to have the device evaluated and repaired, a new service order will be opened and will be captured through philip's normal complaint procedure.
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