RESPIRONICS, INC. RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
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Model Number V60 V60PLUS VENTILATOR |
Device Problem
Volume Accuracy Problem (1675)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/26/2023 |
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 when preparing to use the ventilator, it was found that no matter how the tidal volume was set, it was 0.Stopped using the device and contact the manufacturer for testing and maintenance.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.No medical intervention provided to the patient, nor a delay was noted.Investigation on going.
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Manufacturer Narrative
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No repairs were completed by the field service engineer as the customer declined service and repair; therefore, it could not be determined if it failed to meet specifications.A multi-vendor/clinical engineering department" will handle the service call/incident.Attempts have been made to try to obtain further information about patient use, but no response received from the customer.The investigation concludes that no further action is required at this time.
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Search Alerts/Recalls
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