[16041686]
(b) (4). Fda safety investigation of certain medical device power cords manufactured by electri-cord. So far the following companies have notified users that they may have the recalled electri-cord power cord on their equipment: (b) (4) 12-22-2009: additional companies have been added to the affected power cord list. (b) (4) - i have followed the attached flow chart and have determined that the power cord/plug is affected by the fda recall and is exhibiting one of the characteristics as follows: if the plug has bent or cracked prongs, an outer sheath that is visibly burnt, a black residue, signs of excessive wear and tear. I have taken the following actions: contact of the medical device manufacturer or sales representative to report the power cord failure and to request the appropriate replacement/repair. I have removed the power plug/cord assembly, replaced with a verified correct component, safety tested, and returned equipment back into service. The (b) (4) supervisor has been notified of this work order for the need to report to the fda. (b) (4).
Patient Sequence No: 1, Text Type: D, B5