(b)(4).The previous repair record for intellicart system 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 repair record review found no issues with the device after repair 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 twice, the previous repair being for the valve pack on (b)(6) 2019.This is not associated with the current repair.Thus, this repair was a non-related issue.On (b)(6) 2019 it was reported from fresno surgical hospital that the unit may have started smoking while in use.On (b)(6) 2019 a zimmer biomet authorized repair technician was contacted about the cart and dispatched to be at the site.The technician arrived but was not able to duplicate the issue.With the board and power supply both requiring replacement, he proceeded to replace the control board and power supply and then tested the unit to verify proper operation.The device was tested, inspected, and repaired.Although the service technician was unable to duplicate the reported event, he did however proceed to replace the power supply and control board because they both required replacement.A root cause for the reported event, therefore, cannot be determined.Afterwards, the device was noted to be functioning without any issue.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Device evaluated by manufacturer? evaluated by external contractor.
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