Description of Event or Problem · 0
ESTABLISHMENT: VOCERA COMMUNICATIONS, INC. BUSINESS TRADE NAME: EXTENSION HEALTHCARE 1950 W COOK RD STE 101 FORT WAYNE, IN 46818 REGISTRATION NUMBER: 3010694760, FEI NUMBER: 3010694760, STATUS: ACTIVE DATE OF REGISTRATION STATUS: 2024, OWNER/OPERATOR: STRYKER CORP., 1901 ROMENCE PKWY PORTAGE, MI US 49002, OWNER/OPERATOR NUMBER: (B)(4), OFFICIAL CORRESPONDENT: (B)(4) STRYKER, 3800 E. CENTRE AVE, PORTAGE, MI, 49002, PHONE: 1-269-5678254. THE PRODUCT HAD A CONFIGURATION CHANGE DONE BY A USER WHICH STOPPED A CRITICAL INTEGRATION FOR NURSE CALL. THIS PREVENTED CRITICAL COMMUNICATION OF ADVERSE PATIENT EVENTS SUCH AS BED EXIT, PATIENT REQUEST FOR NURSE, FALLS IN SHOWER, AND FALLS IN THE COMMODE FROM GETTING DELIVERED ELECTRONICALLY TO THE RN. COMPANY CLAIMS THAT THEY DO NOT TRACK THESE EVENTS WHERE A USER CAN ESSENTIALLY TURN EVERYTHING OFF AND IS SOMETHING THAT IS A PRODUCT FEATURE THAT WE CAN REQUEST TO DEVELOP. THIS IS NOT ACCEPTABLE. ANY KIND OF MEDICAL DEVICE SHOULD BE ABLE TO RECORD ALL ENTITIES WHICH MAKE CHANGES TO IT. IF THIS WAS THE SAME BEHAVIOR FOR INFUSION PUMPS INTEGRATED INTO EHR, WE'D HAVE MUCH MORE PATIENT ADVERSE EVENTS. TECHNICALLY SPEAKING ITS ALSO EASILY FEASIBLE TO DO AS WELL, SO IT IS DOUBLY WRONG FOR THEM TO TOUT SOMETHING AS A FEATURE WHEN IT IS THE BASIC DEFAULT IN ALL NON HEALTHCARE RELATED WEB TECHNOLOGIES.