Originally provided information on (b)(6) 2020 by an arjo training and acute application specialist was that the patient's pressure ulcers got worse while being on a bariair bed.The bariair bed in question was delivered to the hospital as a replacement for the other bariair bed where kinked hose was found and where patient developed stage 2 pressure ulcer.Report for the first complaint was submitted under mdr #3007420694-2020-00128.On (b)(6) a following communication was received that the patient passed away due to his health condition, not related to the pressure ulcer.Later, on (b)(6) arjo received a fax, where the customer provided clarification to the complaint stating that they noticed that the newly delivered bariair bed had too little air in the cushions and arjo technician, who visited them could not adjust the pressure, either.On (b)(6) customer provided another feedback stating the patient¿s skin condition did not improve on this new bariair bed allegedly due to the bed not being properly inflated.The bariair bed in question (the bed belongs to german rental fleet) was tested in the service center and no fault was found.Bariair cushions were tested for back pressure and they passed the requirements.Customer allegation could not be confirmed.The bariair system user manual states to monitor patient skin condition regularly and if needed alternative therapies for high acuity patient should be considered: "skin care - monitor skin conditions regularly, particularly at bony prominences and in areas where incontinence and drainage occur or collect, and consider adjunct or alternative therapies for high acuity patients.Early intervention may be essential to preventing serious skin breakdown." the bariair system did not meet customer¿s expectations, therefore citadel plus was offered instead.Customer decided to not renting the bariair system any more.In summary, the bariair bed was used for patient treatment when the alleged lower pressure was noticed and for this reason played a role in the event.The bed did not fail to meet its performance specification, no failure was found during bed¿s inspection.Customer allegation could not be confirmed.The patient did not sustained an injury, skin condition did not worsen while being on this bed.There was no connection between patient¿s death and the bariair system.This complaint was reported in abundance of caution because original information suggested an injury.Following customer clarification, there was no injury sustained and is unlikely a serious injury or death occurs in the future.This complaint is not considered meeting a reportable criteria.
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