This event has been recorded by zimmer biomet under: (b)(4).This medwatch is being filed to relay additional information.The following sections were updated: date of report, udi #, concomitant medical products, pma/510k, if follow-up, what type, device evaluated by mfr, device manufacture date, usage of device.Udi #: (b)(4) product review of the duo fluid cart w/ smoke evac (00514010200) serial number: (b)(4) by a zimmer biomet certified service repair technician on 24 february 2020 revealed that the power inlet module had failed.However, there were no signs of the unit smoking as all wires on the united looked in good working order.The power inlet module was replaced.The technician also found the vacuum pump was an older style so it was proactively replaced.The unit was tested and returned to service.Repair of the device was performed by a zimmer biomet certified service repair technician on 24 february 2020 which included replacement of the following: intellicart power supply (part#: 70097 and lot code#: 0041385).Additional repair included proactively replacing the intellicart vacuum pump capacitor (part#: 70216 and lot code#: 0042731).The device, serial number: (b)(4), was then tested and functioned properly.It was repaired, inspected and tested.The duo fluid cart w/ smoke evac (00514010200) serial number: (b)(4) has been previously repaired/evaluated 2 times as documented in the repair reports in crm.The last repair was 8 march 2019 by a zimmer biomet certified service repair technician where it was reported that the unit was not draining properly.The technician removed a plastic foreign object from cylinder #1.The unit was tested and returned to service.This is not a related issue.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Device is used for treatment.The root cause of the reported issue is attributed to a malfunctioning power inlet module.No corrective actions, preventive actions, or field actions resulted after investigation of this event.The event cannot be confirmed.
|