RESPIRONICS, INC. RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
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Model Number V60 V60PLUS VENTILATOR |
Device Problem
Device Sensing Problem (2917)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/05/2023 |
Event Type
malfunction
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Event Description
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Philips received a complaint by the biomedical engineer (bme) on the v60, indicating that the ventilator was not going into standby mode.It was reported that there was no patient involvement at the time the issue was discovered.The biomedical engineer (bme) reported to the remote service engineer (rse) that the device was not going into standby mode.The rse had the bme check in service mode, and the bme confirmed that the device was showing an average air standard liter per minute (slpm) of -1.1 and -1.3.The rse then informed the bme that was the reason for device not going into standby and suggested that the bme could let the device run in normal operational mode for 2 minutes to see if the values change.The rse also suggested that the bme could also attempt to blow out the flow sensor assembly-- if the device was still failing, the rse recommended that the bme should replace the flow sensor assembly.
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Manufacturer Narrative
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H10: per good faith effort (gfe) response received 11jan2024, the biomedical engineer (bme) stated that it was not necessary to order a replacement flow sensor assembly as there was already one on hand.The bme replaced the flow sensor assembly and verified that the issue was resolved.The device passed the required performance verification tests per philips standard and was returned to service.The investigation concludes that no further action is required at this time.If additional information is received, the complaint file will be reopened.Although requested, the defective parts were not received at this time.A supplemental report will be submitted if the part is received and evaluated.
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