Though no medical/surgical intervention was required to preclude a serious injury in this event, there have been previously reported events involving a similar device that resulted in the need for medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function.Therefore, this event meets the criteria for reportability per 21 cfr part 803.Functional quality testing was not performed since the attachment stopped working post production testing.The reported complaint was confirmed based on production testing.An actual temperature reading was not captured as the attachment stopped working post production testing.A root cause as to why this situation could have occurred could be determined based on quality observations.Both bearings failure, free roaming ball bearings and excessive debris most likely created friction within the head which resulted in temperature increase.Additionally, the attachment failed all production requirements with the exception of illumination testing (sound testing was not performed).
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