This event was recorded with zimmer biomet under (b)(4).Udi (b)(4).The product was evaluated by an external contractor.The previous repair record of intellicart system unit 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 by zimmer biomet surgical 5 times.The last repair was done for carbon filter issue and it is not related to the current repair.On 12 november 2018, it was reported from montefiore medical park that unit was not working properly.The service technician arrived at the site on 16 november 2018 and he was unable to duplicate the concern regarding level sensor, but additionally he noted that vacuum pump was not turning on and vacuum sensor errors 1 &2 in error log, then he confirmed that event was misreported.After that he replaced vacuum pump for the unit and confirmed that the unit was functioning as intended.The service technician then returned the unit back to service without any further concerns.The unit was tested, inspected, and repaired.Service work order dms-47744-f1g9c9 on 12 november 2018.The service technician confirmed that event was misreported for level sensor error, in addition to that he was unable to reproduce the reported event when the unit was inspected and tested on 16 november 2018.The root cause of vacuum issue was due to defective vacuum pump.If the air flow of the unit was disrupted the unit will then read that inadequate pressure is being generated and trigger a vacuum sensor error, vacuum pump will not turn on.Therefore, root cause of the reported event cannot be specifically determined with the provided information.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.
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