RESPIRONICS, INC. RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
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Model Number V60 V60PLUS VENTILATOR |
Device Problem
Defective Alarm (1014)
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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 an unspecified alarm occurred.The device was in use on a patient at the time the reported issue was discovered; however, there was no reported harm to the patient or user.The customer called technical support to report that an unspecified alarm occurred.
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Manufacturer Narrative
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E1: 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 an unspecified alarm occurred.Per good faith effort (gfe) response received on 30may2024, the authorized service provider (asp) engineer stated that the device was not under warranty, and the customer refused to pay for the repair.It is unknown what the outcome of the service event was, and no further information could 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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