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Investigation summary: investigation analysis - bd (plant) quality initiated investigation on the customer report regarding the frequency of events reported on facscalibur lid pivoting on its own weight and hit the user.There was in indication of a defective gas springs losing its pressure to hold the weight of the cytomerter¿s lid.Data/information: manufacturing data dhr: a review of the facscalibur (pn343020, sn# (b)(4)) was conducted last 25jan2019.This instrument was released from manufacturing floor last 03mar1997 with no mechanical issues on the metal lid and gas springs as observed in the dhr.Aside from manufacturing and testing processes, these instruments undergone normal clean up procedure via (b)(4).This includes general cleaning, cosmetics and decontamination of major components, labeling and repackaging prior shipping.General observation: under section 10.0 of the document (b)(4), described relevant label placements, this includes placement of service label, pn95-10050-00 on center top lid at the back of the instrument.This label was confirmed available at the time of the incident.Manufacturing defect trend: there is no instrument and/or component defects recorded for all facscalibur product that relates to gas springs or metal lid mechanical defects therefore no defect trend available at this time.These gas springs were 100 percent unused/brand new when install to cytometer during manufacturing.These components tend to deteriorate over time and can only be assessed during post market activities and servicing.Service history/complaint data: a review of service history record conducted by eu pts team revealed a service record found that indicated the replacement of gas springs was completed last 11aug2005.It was also confirmed that this was the last time the gas springs were replaced.¿sample management task¿ was initiated to request for the return of the alleged gas springs, pn78-10103-00.There were documented attempts to request the return of these gas springs but unable to get result.This is due to the fact that service personnel was not made aware at the time the parts were replaced in the field.The affected parts were discarded prior this request.Complaint trend: a complaint trend review of facscalibur product family resulted only 2 complaints with similar incident occurred between october 2008 to january 2019.There is a total of (b)(4) gas springs that are being consumed world wide in the year of 2012 ¿ 2018.An average of (b)(4) gas springs are being replaced every year.Comparable consumption rate from year 2012-2018.P/n 78-10103-00 gas spring.Consumption: years total qty average 2012; (b)(4); (b)(4).2013; (b)(4); (b)(4).2014; (b)(4); (b)(4).2015; (b)(4); (b)(4).2016; (b)(4); (b)(4).2017; (b)(4); (b)(4).2018; (b)(4); (b)(4).Manufacturing defect trend: due to gas springs installed during manufacturing are new and never been used, there is no recorded cases of non-conformance (qn) related to cytometer lids pivoting off or any signs of premature deterioration of the gas springs can be produced at this time.Risk analysis: a document review of facscalibur product family risk management file, 34273ra rev 07 was conducted on 28jan2019.Referenced to mechanical hazard id (b)(4), the initial and residual risk index is characterized to category 6.This risk has been addressed and mitigated through design change by changing top cover from metal to a light weight plastic that should reduce force of impact minimizing the severity of harm.Also there was a pm document update, 335956 fc fst fcb service manual (rev03) to routinely verify functionality of the gas springs.Any defective gas spring warranted a part replacement during a regular pm cycle.Important observation: there has been no incident, with the exception of this case being recorded since the mitigation controls and field communication has been established to date.There has been a system in place to establish control in the field.The safety incident in this case could have been considered an outlier and subjected to further investigation.Mechanical failure of the gas springs on a sheet metal type facscalibur lid due to age and usages.Gas springs were replaced last 11aug2005 and had lost its pressure to hold the weight of the metal lid.No clear indication of pm activities that involves inspection of the condition of gas springs.No pm records can be obtained during the complaint investigation.General awareness to safety of users and bd field personnel.Failure to periodically communicate safety limitations and guidelines to prevent mechanical hazard associated to the instrument.Based on the evaluation of complaint severity it was determined that there was system in place to continuously monitor the condition of the gas springs.Any defective gas springs are being replaced once identified in the field during the pm cycles.This is the first safety incident that have been recorded since the full implementation of aforementioned changes related to gas springs and facscalibur lids.This complaint mode will be trended and further investigation will be required if an actionable level is reached.
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