RESPIRONICS, INC. RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
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Model Number V60 |
Device Problem
Complete Loss of Power (4015)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/03/2024 |
Event Type
malfunction
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Event Description
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Philips received a complaint from the biomedical engineer (bme) on the v60 ventilator indicating that a 1127 "ovp circuit failed" alarm error appeared on the screen in normal mode.There was no patient involvement at the time the issue was discovered.There was no report of patient or user harm.The remote service engineer verified that the 1127 error code was logged in the event log and advised the bme to follow the repair path that is documented in the v60 manual.The investigation is ongoing.
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Manufacturer Narrative
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H10.Multiple attempts have been made to try to obtain further information about this case, but no response was received from the customer.The complaint will be processed for closure.If additional information becomes available at a later date, the complaint will be reopened, and a supplemental report will be submitted.
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