Returned unit was examined and a stress mark was found in the lower left corner of the drain.A stress mark is indicative of shipping and handling damage.Due to the stresses that caused the stress mark, the cover separated from the body leaving a gap between the cover and body in the air leak monitor (alm) area.Fluid was introduced into the alm per the instructions for use (ifu).The fluid immediately leaked out of the alm due to the gap between the cover and body.The unit was tested for function and the bellows did indicate suction was applied.The suction level achieved was not at the -20 cmh2o that the unit was set at.This was due to the air leak allowed by the gap between the body and cover, allowing air to come into and negate some of the suction applied.The suction level applied by the user may have been less than the standard/recommended level used in lab testing.This could account for their observation that the bellows was not moving.A device history record review could not be performed since the lot number was not provided.Clinical evaluation: the product is protected by an outer box used for shipping and by protective packaging to prevent breakage.If the product box is damaged in shipment, this would likely be noticed on receipt of the product at the facility and the product would not be accepted.The instructions for use advise: "do not use if the package is opened or damaged." the device is supplied sterile and the packaging should be inspected prior to use to ensure it is intact and not damaged.If the product was presented in surgical theater the integrity of the packaging of a sterile device would be noticed prior to being introduced to the sterile field, would be rejected and therefore would not impact the patient.A second device would have to be located and prepared for use.This may represent a delay in therapy.
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