Arjo was informed by a customer about an event involving an arjo auto logic pump.Following information reported, a power cable was damaged by a bed¿s side rail causing a short circuit of the pump, and blacking out several rooms at the customer facility.No injury nor other medical consequences were reported to arjo.During an inspection of the involved device performed by arjo representative, it was found that the main power cable was physically damaged and burnt.The pump was installed on the bed by the customer's staff without use of the cable management system.The damaged occurred when the cable was trapped in the bed¿s side rail mechanism.According to instruction for use (630933en), the user shall ¿make sure that the power cables (¿) are clear of moving bed mechanisms or other possible entrapment areas.The mains power cable of this pump is designed to allow movement of the bed, and should be fitted into the cable management flaps along the sides of the mattress, as described in this manual.¿ the mains cable should be carefully inspected.When any malfunction is noticed, the device should be immediately withdrawn from the use until the service is performed.The complaint was decided to be reportable due to malfunction of the power cord, which resulted in the short circuit of the pump, and blacking out several rooms at the customer facility.The power cord was found to be damaged, and from that perspective, the device did not meet performance specification.The device was in use by the patient when the malfunction occurred.No injury or other medical consequences were reported.
|
Arjo was informed by a customer about an event involving an arjo auto logic pump.Following information reported, a power cable was damaged by a bed¿s side rail causing a short circuit of the pump, and blacking out several rooms at the customer facility.No injury nor other medical consequences were reported to arjo.
|