The complaint is being reported by zimmer biomet as (b)(4).The k081047; k123188; k133786.The product will not be returned to zimmer biomet for investigation because it was evaluated by an external contractor.However, the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product evaluated by external contractor.
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The complaint is being reported by zimmer biomet as (b)(4).The previous repair report for ultra duo flex cart unit serial number 54046, was reviewed and noted no related non-conformances, requests for deviation (rfd) or any other issues with the repair.The previous repair report review found no issues with the device after repair and all verifications, inspections and tests were successfully completed.Mera hmc was contacted about the cart and dispatched a service technician to be at the site.On 01 august 2017, the technician found that the unit was leaking in the valve pack.On 10 aug 2017, he replaced the valve pack twice, but the problem persistence; suspected bottom plate crack.So the exchange was initiated.An exchange for the new cart was scheduled.A new cart was shipped from riverside to the facility (shipping# (b)(4)).On 24 aug 2017, the new cart was confirmed to have been delivered to the facility and premier medical contracting llc was dispatched a service technician to the site to perform exchange.The technician arrived at the site and installed the new cart.He then verified that the cart was functioning as intended and placed the cart into service without further incident.The technician then repackaged the new cart so it can be returned.The exchanged cart was picked up from the facility the exchange cart was confirmed to have been returned to riverside on 01 sept 2017 as noted in zpm 13.0139 a returned equipment log.While the service technician confirmed the reported event and found that the unit was leaking from the valve pack, replacing the valve pack did not resolve the issue and the cart was exchanged.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 obtained throughout the follow-up process.
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