It was reported to arjo that a nurse suffered an electric shock after she touched the power cord which had been detached from the nimbus pump.The nurse complained on pain on the left side of her body in the hand, arm and shoulder area.An electrocardiogram (ecg) was carried out and no problems were detected.During an on-site visit, an arjo technician checked the involved device and found that the pump power cord was pulled out of the grommet point exposing the internal copper wires.The customer informed that the cable was pulled out from the pump when the patient's dad stepped on it.The alerted nurse picked up the damaged but still connected to the power socked power cord thinking that the power to the pump was switched off.The investigation conducted by the customer showed three possible causes that may lead to the event.A.The power cord was lying on the floor which means that it was positioned inadequately.The instruction for use (ifu), document 151996en warns ¿make sure that the mains power cable and are positioned to avoid causing a trip or other hazard, and are clear of moving bed mechanisms or other possible entrapment areas.Where cable management flaps are provided along the sides of the mattress, these should be used to cover the mains power cable.¿ b.The pump power cord was not suitably internally secured in the clamp.In result, when the cable was under tension, it detached from the grommet point.However even if the power cable was suitably secured, it may have still become disconnected.C.Miscommunication occurred, the nurse picked up the damaged power cord thinking that the power to the pump was switched off.No additional event was reported to us pressing the same issue.Based on the above, it was concluded that the electric shock occurred due to touching of the power cord connected to the power.The complaint was assessed as reportable due to allegation about the electric shock (non-serious).The pump was malfunctioned (the cable was detached) therefore the device did not meet specification.The pump was in use by a patient when the claimed issue occurred.
|