RESPIRONICS, INC. RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
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Model Number V60 V60PLUS VENTILATOR |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/03/2023 |
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 they need to secure the unit to the universal stand.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 v60 needed to be secured to the universal stand.The rse provided the bme with the part numbers of the thumbwheels, gray foot kit, and central processing unit (cpu) tray.The bme informed the rse that the parts will be ordered to repair the device.The investigation is ongoing.
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Manufacturer Narrative
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The biomedical engineer (bme) reported to the remote service engineer (rse) that the v60 needed to be secured to the universal stand.The rse provided the bme with the part numbers of the thumbwheels, gray foot kit, and central processing unit (cpu) cover tray.The bme informed the rse that the parts will be ordered to repair the device.Per good faith effort (gfe) response, the bme stated that the mounting screw broke, and the cause was possibly due to the fact that the devices get moved around and bump into things.The bme also confirmed that once the thumbwheels, gray foot kit, and cpu cover tray were ordered and replaced, and the reported issue was resolved.The investigation concludes that no further action is required at this time.If additional information is received, the complaint file will be reopened.Additionally, the bme mentioned that the damaged parts were thrown away.
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