This complaint is recorded with zimmer biomet under (b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, product evaluated by external contractor.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.The device history record (dhr) review for intellicart system serial number (b)(4), noted no related non-conformances, requests for deviation (rfd), change notices (cn), or any other issues with manufacturing.The dhr review found no issues with the device and all verifications, inspections, and tests were successfully completed.The device was noted to have not been previously repaired by zimmer biomet surgical.On (b)(6) 2017, it was reported from (b)(6) that the unit was leaking fluid.Pm medical was contacted about the unit and dispatched a service technician to be at the site.On (b)(6) 2017, the technician found that the unit was issuing drain error and performed the backflush to resolve the drain error.While performing the backflush, he noted that the unit was leaking fluid from the receiver and suspected the leaking was due to back pressure.He performed a full soak cycle and then verified that the cart was functioning as intended.The technician then returned the cart to service without further incident.While the service technician confirmed the reported event and the device was noted to be functioning as intended after a full soak was performed, it is unknown with the information provided as to what actually caused the leaking from cart.Therefore, based on the information provided, a specific root cause of the reported event cannot be determined.The investigation was based on the information that was provided initially and any information that was.
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