It was reported that during install/pm/in-service, there was an issue with the cord.The cord was frayed, but there was no harm/injury or shock to anyone.There were no smoke, sparks or burning smell either.No adverse events were reported as a result of this malfunction.
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This event has been recorded by zimmer biomet under (b)(4).4316 - appropriate term/code not available - cord was damaged over time.The previous work order in customer relationship management (crm) for ultra duo flex fluid cart serial number (b)(4) was reviewed and noted no related non-conformances, requests for deviation (rfd) or any other issues with the repair.The previous work order noted no issues with the device after repair and all verifications, inspections and tests were successfully completed.The dhr review found no issues with the device and all verifications, inspections, and tests were successfully completed.Using crm to query for serial number (b)(4), the device was noted to have been previously repaired 6 times, the previous repair being for the unit not draining properly on 28 march 2018.The cylinder drain is not associated with the current repair.Thus, this repair was a non-related issue.On 23 september 2019, it was reported from russellville hospital that there was an issue with the cord.On 23 september 2019, a zimmer biomet certified service repair technician was contacted about the cart and dispatched to be at the site.On 23 september 2019, the technician arrived at the site and confirmed that there was an issue with the cord; it had frayed/separated.The technician replaced the power cord (part #91822) and then verified that the unit was functioning as intended.The technician then returned the unit to service without further incident.The device was tested, inspected, and repaired.Service work order (b)(4) on 23 september 2019.The root cause for the reported cord issue was due to the power cord fraying/separating.Through regular use, the power cord or plug can become damaged over time, causing the reported concern.The reported event was confirmed during inspection of the device and the device was noted to be functioning as intended after the power cord was replaced.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Review of the information provided during the investigation determined there is no further actions needed at this time (ie/capa/scar/hhe/d).This complaint will be tracked and trended for any adverse trends that may warrant further action.
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