Description of Event or Problem · 1
URGENT MEDICAL DEVICE RECALL: MODEL 660, 1231, 1731, AND 1025 STRYKER MEDICAL STRETCHERS WITH THE RETRACTABLE CORD REEL OPTION ONLY; MFG BETWEEN JUNE 2003 THROUGH FEB 2010. STRYKER MEDICAL IS INITIATING A VOLUNTARY RECALL OF AFFECTED STRETCHERS MFD WITH CERTAIN POWER CORDS. THE CORRECTION INVOLVES STRETCHERS FITTED WITH POWER CORDS MFG BY ELECTRI-CORD (ECM). THESE POWER CORDS HAVE A PLUG WITH A PRONG AND GROUND-PIN INSERT DESIGN, WHICH CAN BE IDENTIFIED BY A BLACK PLASTIC BRIDGE CONNECTING THE TERMINAL PRONGS ON THE PLUG. THIS PROBLEM WAS ORIGINALLY IDENTIFIED BY OTHER MEDICAL DEVICE MFRS WHO HAD REPORTS OF ECM POWER CORD FAILURES THAT RESULTED IN SPARKING, CHARRING, AND/OR FIRE, ON OCCASION, WHEN USED WITH THEIR PRODUCTS. SEVERAL FIELD CORRECTIONS OF THE ECM POWER PLUGS RESULTED. RECENTLY HOWEVER, STRYKER MEDICAL HAS RECEIVED SIMILAR COMPLAINTS FROM OUR CUSTOMERS REGARDING THE AFFECTED ECM POWER CORD WHICH INDICATE IT IS POSSIBLE FOR A FRACTURE OF THE PRONGS TO DEVELOP INSIDE THE MOLDED SECTION OF THE PLUG AND WHICH HAS RESULTED IN MELTING AND CHARRING. WHILE NO INJURIES HAVE BEEN ASSOCIATED WITH THE USE OF OUR PRODUCTS IN THESE REPORTED EVENTS, WE HAVE DETERMINED THERE IS A POTENTIAL THAT PT OR CAREGIVER SAFETY MAY BE COMPROMISED. THE POTENTIAL RISKS FROM THESE POWER CORD FAILURES INCLUDE ELECTRICAL SHOCK, DELAY IN SETUP AND THERAPY, INTERRUPTION OF THERAPY, DEVICE FAILURE AND FIRES; WHICH MIGHT CAUSE SERIOUS INJURY OR DEATH. STRYKER REPAIRED.