PORTABLECONNECT

Additional Manufacturer Narrative

ROM TECHNOLOGY'S INCIDENT RESPONSE PROTOCOLS WORKED AS DESIGNED (I.E., THE SAFETY/ESCALATION PROCESS FUNCTIONED PROPERLY). THE ISSUE WAS IDENTIFIED, CORRECTED, AND VALIDATED BY QA THE SAME DAY. A DEFECT IN THE PATIENT UPDATE API CAUSED A CRITICAL CARDIAC SAFETY FIELD TO BE SET TO NULL, WHICH ALLOWED A PATIENT TO BYPASS THE REQUIRED PRE-CALL. THE INCIDENT WAS NOT CAUSED BY ONE ISOLATED MISS, BUT BY A COMBINATION OF: · DEFECTIVE UPDATE LOGIC, · INSUFFICIENT REGRESSION COVERAGE AROUND EXISTING CARDIAC PATIENT EDITS, · AND MISSING SYSTEM SAFEGUARDS TO PREVENT INVALID PRODUCTION DATA. CORRECTIVE ACTIONS HAVE BEEN TAKEN, AND ADDITIONAL PROTECTIONS ARE BEING ADDED AT THE DATABASE, API, TESTING, AND MONITORING LEVELS.

Description of Event or Problem

PATIENT WAS ABLE TO START REHAB ON HER OWN WITHOUT A CARDIAC REHAB SPECIALIST CALL. PATIENT WAS ABLE TO PEDAL FOR 19 MINUTES UNSUPERVISED. CARDIAC REHAB SPECIALIST CALLED AND CONNECTED WITH PATIENT, HE STOPPED EXERCISE AS SHE REPORTED 9/10 SHORTNESS OF BREATH. SHE WAS ALLOWED TO SIT AND REST FOR A BIT. SYMPTOMS DID NOT IMPROVE. PATIENT'S PHYSICIAN WAS CALLED AT 4:18PM CST AND WAS LET KNOW OF THE SITUATION, HE RECOMMENDED THAT EMS BE SENT TO THE PATIENTS HOME. THE PATIENT DID NOT RECEIVE TREATMENT FOR ANY LIFE-THREATENING CONDITION AND ANY IMPAIRMENT WAS PREVENTED BASED ON PATIENT'S RELEASE FROM THE HOSPITAL WITHOUT ADMISSION. THIS WAS THE RESULT OF A SOFTWARE BUG THAT ALLOWED THE FIELD "NO_SESSION_ALLOWED_WITHOUT_CALL" BEING SET TO NULL. THE ISSUE WAS FIXED THE SAME DAY AS THE INCIDENT WITH A SOFTWARE UPDATE, AND ADDITIONAL PROTECTIONS ARE BEING ADDED AT THE DATABASE, API, TESTING, AND MONITORING LEVELS.