Icu rn who is also the educator, called to question whether the suction tubing could be direct from the wall regulator to the drain, or had to go through a suction canister (collection canister).She expressed dissatisfaction with the diagram for setup that she found online, as well as the fact that no instructions come with the individual drain.It was explained to her that it is irrelevant whether a suction canister is used or not, as long as all the openings on the canister are capped.She was pleased with the help and looks forward to contact from her local rep regarding available posters, etc.She describes their facility as infrequent users, but that this is the drain they always use.
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A complaint was submitted as a result of a technical support call received regarding oasis 3600-100 and a question on suction application.The complaint details state: "icu rn who is also the educator, called to question whether the suction tubing could be direct from the wall regulator to the drain, or had to go through a suction canister (collection canister).She expressed dissatisfaction with the diagram for setup that she found online, as well as the fact that no instructions come with the individual drain.I explained that it is irrelevant whether a suction canister is used or not, as long as all the openings on the canister are capped.She was pleased with the help and looks forward to contact from her local rep regarding available posters, etc.She describes their facility as infrequent users, but that this is the drain they always use." the territory manager subsequently provided the hospital with oasis wall posters, wallet cards, and personal guide booklets.In addition, in-service training was conducted with the staff.There is no specific device involved in this complaint and no report of device malfunction; therefore, a device evaluation is not required and the complaint is not considered confirmed.As requests for technical support that do not involve possible malfunction/failure are not considered complaints therefore, the focus of this investigation is on the reported dissatisfaction with the labeling configuration (i.E.The fact that no instructions come with the individual drain), and a review of the content of the labeling provided with the drain in regards to suction setup.The ifu was found to contain adequate instruction regarding suction setup.A number of warnings and precautions to ensure proper setup and function of the drain and description of the various features of the drain.There is an image of the drain and features provided, which clearly denotes the suction control regulator, suction monitor, and suction port.The ifu does not require the use of a canister or collection chamber in order to use suction.The iconic ifu provides a graphical depiction of the drain setup, including connection of the suction line, adjustment of the suction regulator, and bellows monitor.A risk review was performed, which concluded that the device is operating within its approved risk profile, and that the risk analysis adequately covers this complaint.Based on the investigation, no labeling deficiencies have been identified with regard to the use of suction.The ifu does not require the use of a suction canister.With regard to the user dissatisfaction with the ifu configuration (i.E.The fact that instructions are not provided with the individual drain), there have been no other related complaints since october 2020.Therefore, root cause is user - user preference issue.H3 other text: no device available.
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