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Patient 1
(B)(4). DEVICE PRODUCT CODE: JOW. (B)(4). COULD NOT CONFIRM THE ALARM ISSUE. REPLACED THE DAMAGED POWER CORD AND FACE LABEL. THE REPORTED EVENT, "CP/OP" IS NOT CONFIRMED AND "POWER CORD DAMAGE AND OPEN WIRES" ARE CONFIRMED. THE REPORTED EVENT "CP/OP" WAS NOT CONFIRMED SINCE THE DEVICE FUNCTIONED AS INTENDED DURING PRODUCT REVIEW; HENCE, A ROOT CAUSE CANNOT BE DETERMINED. THE INVESTIGATION WAS BASED ON THE INFORMATION THAT WAS PROVIDED INITIALLY AND ANY INFORMATION THAT WAS OBTAINED THROUGHOUT THE FOLLOW-UP PROCESS. DAMAGE TO THE POWER CORD CAN OCCUR BY THE CORD/PLUG MOLD BEING RUN OVER BY WHEELED EQUIPMENT OR BY THE CORD BEING PULLED FROM THE WALL OUTLET INADVERTENTLY. IN SOME CASES, DAMAGE TO THE WIRE COVERINGS AND INSULATION MAY EXPOSE THE WIRES OF THE CORD WHEN EXCESSIVE FORCE IS APPLIED IN A CLINICAL SETTING. UNDER NORMAL CONDITIONS THE POWER CORD AND PLUG MOLD ARE NOT LIKELY TO BECOME DAMAGED. FOR VP500DM: THE AVERAGE AGE OF THE POWER CORD DURING REPLACEMENT IS 2.5 YEARS. THE FAILURE RATE FOR THE POWER CORD IS (B)(4)%. REVIEW OF THE INFORMATION PROVIDED DURING THE INVESTIGATION DETERMINED THERE IS NO FURTHER ACTIONS NEEDED AT THIS TIME (IE/CAPA/SCAR/HHE/D). THIS IS A WELL-KNOWN FAILURE MODE, WITH NO ALLEGATIONS OF HARM OR INJURY. THIS COMPLAINT WILL BE TRACKED AND TRENDED FOR ANY ADVERSE TRENDS THAT MAY WARRANT FURTHER ACTION.