Model Number OPTICAL DISTANCE SENSOR |
Device Problem
Calibration Problem (2890)
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Patient Problem
No Patient Involvement (2645)
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Event Date 08/30/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The device has not been evaluated yet for investigation purpose.Once the evaluation is performed, a follow-up medwatch report will be submitted.(b)(4).
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Event Description
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During a routine quarterly preventive maintenance (performed by a zimmer biomet employee, and in which there was no patient involvement), the distance sensor (sn: (b)(4)) failed to calibrate (calibration plate sn: (b)(4)) during the ¿(b)(4)¿ software-guided calibration checks.The distance sensor also failed to calibrate during the applicative test, thus prohibiting the use of contactless registration of the mannequin.
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Event Description
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During a routine quarterly preventive maintenance (performed by a zimmer biomet employee, and in which there was no patient involvement), the distance sensor (sn: (b)(6)) failed to calibrate (calibration plate sn: (b)(6)) during the ¿kineverif¿ software-guided calibration checks.The distance sensor also failed to calibrate during the applicative test, thus prohibiting the use of contactless registration of the mannequin.
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Manufacturer Narrative
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This optical distance sensor s/n (b)(6) has been released conform from the manufacturing site on 11-jun-2019.Further testing on this part was performed on 07-oct-2019 by a company representative.The optical distance sensor box was unplugged and re-plugged ; and its cable was checked for damages.Then, 04 accuracy tests were performed - three with the original cable, one with a different cable as a control - all passed.The event described in the complaint is confirmed as it was noted by a trained company representative.On this occasion the root cause from the reported event can not be determined - it may be due to an incorrect plugging or to a false contact.The optical distance sensor was used without any reported issue during the preventive maintenances performed on (b)(6) 2020 and (b)(6) 2020.
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Search Alerts/Recalls
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