The following description of the event was documented by a carefusion technical support specialist in response to an email from the distributor in australia."oxygen concentration readings failed pre-delivery inspection out of spec.Out of box failure 21:24.4, 30:30.7, 60:57.8, 90:86.4, 100:97.1".
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(b)(4).The alleged faulty device was received by carefusion on march 10, 2015, routed to the carefusion failure analysis lab and staged for evaluation.Once the evaluation is complete, a follow-up medwatch report will be submitted.
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Failure analysis: microblender pn: 10049a, sn: (b)(4) was received into the carefusion failure analysis lab for investigation.The carefusion failure analysis lab technician examined the microblender and found that it is out of calibration.The microblender was tested on test station # 10464 per drs 91640 and found that it is out of calibration at 21%, 60% o2.At end point calibration sequence # 1, 21%, spec.Is 20.9 to 22.9% reads 22.1%.At set point calibration sequence # 3, 60%, spec.Is 58.0 to 62.0% reads 58.3%.At set point calibration sequence # 4, 90%, spec.Is 88.0 to 92.0% reads 89.5%.At set point calibration sequence # 5, 100%, spec.Is 98.0 to 100.0% reads 98.5%.At set point calibration sequence # 8, 60%, spec.Is 57.0 to 63.0% reads 54.8%.Additional issue related to complaint; at set point calibration sequence # 2, 30%, spec.Is 28.0 to 32.0% reads 27.5%.The microblender was recalibrated by adjusting the control knob.Finding/root-cause: the microblender was out of calibration at 60% but was not out of calibration at 21%, 90% and 100%, as alleged, but was out of calibration at 30%.
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