Please note that previous medwatch reports for this product may have been submitted under the following registration numbers: 1000381138, 3007420694.Currently, these products are to be handled by arjohuntleigh (b)(4) complaint handling establishment and any medwatch reports will be submitted under registration 3005619970.The investigation is ongoing.Results of the analysis will be provided to the follow-up report.
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It was reported by a customer representative that one of customer's employees received an electrical shock from a nimbus 3 pump power cable.It was also indicated that there was an electrical arc observed by the firefighters.There was no allegation that any patient was involved.It is unknown if any medical intervention was needed.The sale representative contacted with the customer to clarify the circumstances of the event and establish details related to employee outcome.The customer answered only that the cable was damaged in a local emergency situation and no other additional information has been revealed.The involved pump was part of a rental fleet.It was picked up from the customer following the event.Based on photo of the involved device, the power cord was broken in two pieces.It seems the most probable that the sparks were caused by the pump¿s power cord breakage and therefore the customer mentioned that the electrical arc was observed by the firefighters.Electric shock was felt after touching a mechanically damaged power cord, which was connected to the power.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.¿ the complaint was assessed as reportable due to allegation of an electric shock sustained by the employee.The pump malfunctioned (the cable was mechanically damaged, broken in two pieces) therefore the device did not meet specification.It is unknown if the pump was in use by a patient when the claimed issue occurred.It is unknown how the power cord was damaged and whether the power cord was securely placed in the cable management flaps.
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