Investigation has been carried out onto this incident and conclusions are following.Arjo was informed about a patient fall from arjo auto logic mattress and non-arjo bed frame (brand name was not provided).It is unknown if safety sides were in raised position or lowered.Specific patient medical condition was not provided.No allegation of product malfunction was reported by the customer.The product user guide instruction for use (ifu) number (b)(4) warns: "it is responsibility of the care giver to ensure that the user can use this product safely." "whilst the patient is unattended, the decision to use safety sides should be based on clinical assessment and in line with local policy".When reviewing reportable complaints for patient fall, we have found some incidents of patient fall, and 10 incidents have been reported by the one group of facilities from french market.After the events, arjo takes this matter very seriously and this is why arjo quality director for french market contacted the customer to help working on identifying the root cause of the issue.The customer facility representative stated that they are considering assessing patients on admit in order to select air mattresses for individual patient's needs.In conclusion, the arjo auto logic system (both mattress and pump) was used while the event occurred, therefore it played role in the event, however there was no allegation of device malfunction.The circumstances of the event, patient medical condition or bed frame used are unknown.Therefore, it is not possible to determine the exact root cause of patient fall.We report this event due to allegation of patient fall, which may lead to serious health consequences.
|