RESPIRONICS, INC. RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
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Model Number V60 |
Device Problem
No Display/Image (1183)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/29/2024 |
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 display was dim.It was reported that there was no patient involvement at the time the issue was discovered as the device was removed from service.The biomedical engineer (bme) called technical support to report that the display was dim.The remote service engineer (rse) provided the bme with the parts identification (id) for the v60 parts that are needed to upgrade a first-generation hydis display to a second-generation nec display.The rse also advised the bme that the service manual references the 2 versions of the liquid crystal display (lcd) for repair.Investigation is ongoing.
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Manufacturer Narrative
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H1-: (b)(6).
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Manufacturer Narrative
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Per good faith effort (gfe) response, the bme stated that the 6 parts that are needed to upgrade a first-generation hydis display to a second-generation nec display were ultimately ordered.After installing the parts and successfully performing performance verification tests (pvt), the bme verified that the issue was resolved, and the device 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.
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