RESPIRONICS, INC. RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
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Model Number V60 |
Device Problem
Excess Flow or Over-Infusion (1311)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/22/2023 |
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 per the staff, the device was reading high tidal volumes.The device was in use on a patient at the time the reported issue was discovered.The device was swapped with another ventilator, but there was no reported harm to the patient or user.The customer reported to the remote service engineer (rse) that the device gave a high tidal volume alarm while in use and requested troubleshooting assistance.The rse advised the customer to perform a performance verification test (pvt) on the device and verify functionality.The rse also mentioned that the factory default setting could be restored to see if there was a setting error.
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Manufacturer Narrative
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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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Search Alerts/Recalls
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