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On (b)(6) 2015 arjohuntleigh received a customer complaint where it was indicated that a resident slid off the bed and became entrapped in the bed rails of his bed which is air inflated / pressurized while lying on the maxi slide purple sheet.The resident sustained a laceration on the left side of the neck.The resident was transferred to hospital for assessment and returned to the facility within the same 24 hour period.Following a facility investigation, it was determined 2 days later that the maxi slide purple repositioning system was left underneath the male resident for care at which time during the night shift incident occurred.On (b)(6) 2015 additional information regarding the event was received: there was no bed linens directly on the mattress of the bed at the time of the incident.Resident was found with head entrapped around bedrails, with remaining portion of body on the floor.Resident was taken to hospital for assessment.He was not admitted.It was noticed that areas have resolved and healed currently.Bed that incident occurred on is a low air mattress bed, and is not manufactured by arjohuntleigh but (b)(6).
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An investigation was carried out into this complaint.Based on the information gathered it appears most likely that the maxi slide sheet was left underneath the patient for care during the night shift.It was indicated that the patient slid off and became entrapped in the bed rails of his bed which is air inflated.Review of reportable complaints for maxi slides showed that there are no related events where a person slipped out of sliding sheet.Therefore, the incident described above seems to be an isolated event to date.It can be established that the slide was being used for patient care when the event took place, and as such it appears the device played a role in the event outcome.The maxi slide involved was not inspected due to put back into circulation, however no malfunctions were indicated by the facility regarding this device.Sliding sheets are using for repositioning a person in the bed and for lateral transfer and have a low coefficient of friction and are extremely slippery that is why care must be taken.They are generally removed once the maneuver is complete, but in some circumstances e.G.At night to allow patients more independent movement, they may be left in place.In these circumstances a suitable assessment must be carried out to ensure the patients safety.However, a usage an interface such as a cotton sheet is required to leave the product under the patient.Following the information received the maxi slide was left directly underneath the patient and this was contributing factor resulting in the patient's fall and the entrapment.The ifu supplied with maxi slide contains crucial safety information: "please ensure that the maxislide, maxitube, maxitransfer are always packed away or hung up after use in order to prevent people accidentally slipping on them." "the maxislide, maxitube, maxitransfer are not designed to be left directly under the patient.However in the case where there is a need for long term patient positioning in bed, it may be possible, based on a clinical evaluation of the patient and using an interface such as a cotton sheet, to leave the product under the patient." consequently to the above, we come to the conclusion that the event was most likely caused by use error, based on the customer information provided.Following the above, it is clearly shown that when the ifu had been followed, the event would have been avoided.Please note that the customer was visited and interviewed by a local arjohuntleigh representative.The training provided for the staff counts as insufficient and in that fact all users must be trained as per ifu.Arjohuntleigh suggests to remind the staff involved of the device labelling.This is to be communicated to the customer.
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