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/corrected: b4, g4, g5, g7, h1, h2, h3, h4, h6, h10.Device evaluations results/investigation findings: on dec 20, 2019 the technician reviewed this unit and confirmed the tandem warning concerns for both cylinders.He also noted that the a/d value for cylinder 1 was reading 627.He replaced both the cylinder 1 level sensor and cylinder 2 sensor.He noted no further concerns with the unit root cause: the level sensor is required to read and report fluid level in the cylinders in order for the unit to function as intended.Application-based failure modes: tandem and range errors occur due to user error.Tandem errors populate when the device¿s software detects an incorrect fluid level measurement in one or both cylinders often when the user introduces fluid into the cylinder after the pump has shut off due to the cylinder being full.Tandem errors are a result of fluid levels increasing without the vacuum system being turned on.Due to a range of external (non-design / non-manufacturing related) variables potentially impacting the component, identifying definitive causes for each level sensor failure is generally not possible.Conclusion: review of the information provided during the investigation determined there is no further actions needed at this time.Valve pack failures are a well-known failure mode, with no allegations of harm or injury to a patient.This complaint will be tracked and trended.Complaint trending procedure for any adverse trends that may warrant further action.
|