On (b)(6) 2018, arjo representative ((b)(6) operator) received a call from the customer (b)(6) hospital located in (b)(6) regarding inability to open pelvic buckle during active cpr.The nurse stated that accessing the patient (male, weight (b)(6)lbs) was difficult because the prone pack could not be unbuckled despite several people trying to push on the pack to loosen it and it interfered with the code blue.An arjo service center team leader stated that when the service technician went to the facility to help release the buckle, the patient was still in the bed and the patient had expired.The patient was large in size, both tall and heavy (described by the technician as having a large midsection).Buckles are used to restrain a patient on the rotoprone when the patient is in supine and prone therapy.The buckle assembly functions much like a seat belt buckle with webbing connected on the right and left side of the bed and a tongue and buckle that get latched in the center of the bed to restrain the patient.The operator of the device clicks the male and female component of the buckle together and tightens the pack straps.The buckle is released by pressing the red button inside the buckle.Bed evaluation performed on (b)(6) 2018, revealed that there was no buckle failure, the involved part was engaged and disengaged several times without issues.One part was found faulty - the axilla adjustment mechanism did not lock.This however had no impact on the buckle release mechanism.The issue reported by the customer was recreated.An accessory bag was placed on the patient surface, the straps from proning packs were pulled very tightly.When attempting to open the buckle it was noticed that the red button was difficult to push to unbuckle the buckle.To open the buckle, a force was applied on the proning pack pushing it down to reduce the tension built in the buckle release mechanism.The customer allegation has been confirmed.Two possible causes have been identified: proning pack strap was pulled too tightly or the patient could have become swollen from iv therapy causing the straps to get tighter.Please note also, that the rotoprone bed was quality control (qc) checked before the delivery to the customer on (b)(6) 2018 and passed the manufacturer's requirements.User manual (#208662-ah rev.D), which is provided with each device, contains all crucial warnings, cautions and instruction which should be followed to ensure the patient safety.In the document following information can be found: the instruction how to secure pack straps during patient placement, "first push downward on pack with one hand, then tighten the strap with the other hand" "tightness of pack straps will vary according to each patient's needs.Straps need to be as tight as can be tolerated", "do not place pelvic proning packs over the upper abdomen.Placement of the pelvic packs should allow for abdominal expansion during therapy" "ensure all proning pack buckles are securely fastened and straps adequately tightened".In summary, the arjohuntleigh device played a role in the event as it was used for the patient treatment.The device failed to meet its performance specification because of inability to open the buckle during active cpr.We are reporting this event to the competent authority because of the patient's death.
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