INGENIA

Additional Manufacturer Narrative

IT WAS REPORTED THAT A MALE PATIENT WAS UNDERGOING A SIMPLE LUMBOSACRAL SPINE MRI UNDER GENERAL ANESTHESIA, WITH A DURATION OF 30 MINUTES. AT THE TIME OF THE INCIDENT, THE PATIENT SUSTAINED A SKIN INJURY, A LACERATION WHILE ENTERING THE ACHIEVA (D STREAM) RESONATOR. IT HAD OCCURRED DUE TO THE ABSENCE OF THE QUADRATURE BODY COIL SEALING ADHESIVE. DESPITE THE USE OF AN ARM SUPPORT, THE INJURY IS OBSERVED WITH REDNESS AND TRACES OF BLOOD. THE INJURY WAS LOCATED ON THE RIGHT FOREARM, DISTAL MIDDLE THIRD, AND THE SIZE OF THE WOUND IS REPORTED AS LESS THAN 1 CM. A NURSING ASSISTANT CLEANED THE AREA WITH SALINE SOLUTION AND, ONCE DRY, APPLIED FATTY ACIDS (LINOVERA TOPICAL SOLUTION). THE WOUND IS EXPECTED TO HEAL COMPLETELY AND THE PATIENT REMAINED STABLE. THE REPORTED INJURY MEETS THE CRITERIA FOR A MINOR NON-SERIOUS INJURY, AND THE TREATMENT ADMINISTERED IS CONSIDERED FIRST AID. BASED ON THE RESULTS OF THE ANALYSIS, IT WAS DETERMINED THAT THE PRODUCT HAS MALFUNCTIONED AND THE MOST LIKELY CAUSE OF THE REPORTED PROBLEM WAS THE BORE SEAL ISSUE. THE QBC SEAL THAT WAS MISSING WAS INSTALLED AND THE SYSTEM WAS HANDED BACK TO THE CUSTOMER FOR USE.

Description of Event or Problem

PHILIPS RECEIVED A REPORT THAT A MALE PATIENT SUSTAINED A SKIN INJURY, A LACERATION WHILE ENTERING THE ACHIEVA (D STREAM) RESONATOR. THE INCIDENT OCCURRED DUE TO THE ABSENCE OF THE QUADRATURE BODY COIL SEALING ADHESIVE. THIS SEAL IS USED FOR PROTECTION, TO AVOID THE PATIENT FROM POTENTIALLY CONTACTING THE SHARP EDGES OF THE MAGNET COVERS. IF THIS SEAL IS MISSING IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY. THE INJURY IS OBSERVED WITH REDNESS AND TRACES OF BLOOD. THE INJURY WAS LOCATED ON THE RIGHT FOREARM, DISTAL MIDDLE THIRD, AND MEASURED LESS THAN 1 CM. A NURSING ASSISTANT CLEANED THE AREA WITH SALINE SOLUTION AND, ONCE DRY, APPLIED FATTY ACIDS (LINOVERA TOPICAL SOLUTION). THE WOUND IS EXPECTED TO HEAL COMPLETELY AND THE PATIENT REMAINED STABLE. NO PHOTOGRAPH WAS AVAILABLE FOR ASSESSMENT. AT THE TIME OF THE INCIDENT, THE PATIENT WAS UNDERGOING A SIMPLE LUMBOSACRAL SPINE MRI UNDER GENERAL ANESTHESIA, WITH A DURATION OF 30 MINUTES. THE REPORTED INJURY MEETS THE CRITERIA FOR A MINOR NON SERIOUS INJURY, AND THE TREATMENT ADMINISTERED IS CONSIDERED FIRST AID.