ACHIEVA 3.0 T

Additional Manufacturer Narrative

PHILIPS HAS STARTED AN INVESTIGATION, A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

Description of Event or Problem

PHILIPS RECEIVED A REPORT THAT THE PATIENT'S FINGER WAS CAUGHT IN THE TABLE LEADING TO A FRACTURE. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER DECLINED ONSITE SERVICE FOR INVESTIGATION. BASED ON THE AVAILABLE INFORMATION, THE EXACT TIMING OF THE INCIDENT WAS UNSURE BUT IT MAY HAVE OCCURRED WHILE THE PATIENT WAS BEING MOVED OUT OF THE MRI SCANNER IN THE HORIZONTAL DIRECTION. THE PATIENT SUSTAINED A FINGER FRACTURE WITH NO INFORMATION REGARDING THE PATIENT OUTCOME NOR ANY INFORMATION ABOUT THE MEDICAL INTERVENTIONS PROVIDED. THEREFORE, WE HAVE DECIDE TO REPORT THIS EVENT OUT OF AN ABUNDANCE OF CAUTION.

Description of Event or Problem

PHILIPS RECEIVED A REPORT THAT THE PATIENT'S FINGER WAS CAUGHT IN THE TABLE LEADING TO A FRACTURE. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER DECLINED ONSITE SERVICE FOR INVESTIGATION. BASED ON THE AVAILABLE INFORMATION, THE EXACT TIMING OF THE INCIDENT WAS UNSURE BUT IT MAY HAVE OCCURRED WHILE THE PATIENT WAS BEING MOVED OUT OF THE MRI SCANNER IN THE HORIZONTAL DIRECTION. AS THE PATIENT SUSTAINED A FINGER FRACTURE WITH NO INFORMATION REGARDING THE PATIENT OUTCOME NOR ANY INFORMATION ABOUT THE MEDICAL INTERVENTIONS PROVIDED. THIS REPORTED INJURY MEETS THE CRITERIA FOR SERIOUS INJURY.

Additional Manufacturer Narrative

BASED ON THE RESULTS OF THE ANALYSIS, IT WAS DETERMINED THAT THE PRODUCT HAS NOT MALFUNCTIONED. THE ROOT CAUSE OF THIS FINGER PINCHING RELATED INCIDENT IS USE ERROR. THE USER HAS NOT STRICTLY FOLLOWED THE SAFETY INSTRUCTIONS AND WARNINGS TO PROTECT THE PATIENT. THE FINGER PINCHING RELATED INCIDENT COULD HAVE OCCURRED DUE TO MISUSE BY A PERSON WHO WAS EITHER UNTRAINED AND UNSUPERVISED (VIOLATION OF THE IFU AND LOCAL SAFETY PROCEDURES), OR BY A TRAINED EMPLOYEE WHO WAS NOT FOLLOWING THE IFU AND/OR WAS ALSO IGNORING THE WARNING LABELS (CONSCIOUS DECISION TO ACT IN OPPOSITION TO TRAINING AND/OR NORMAL USE INSTRUCTIONS). IN ADDITION, LIKELY NO ARM BOARDS (PROTECTIVE MEASURES TO PREVENT FINGER PINCHING) WERE USED AT THE TIME OF THE ALLEGED HARM (WHICH, AS STATED IFU, SHOULD HAVE BEEN PROVIDED TO PREVENT THE PATIENT FROM GRABBING AROUND THE TABLE SIDES AND PINCHING THE FINGERS DURING HORIZONTAL TABLE MOTION, WHICH IS WHAT HAPPENED IN THIS EVENT). THIS IS CONSIDERED AN UNFORTUNATE INCIDENT THAT COULD HAVE BEEN PREVENTED. THE INSTRUCTIONS FOR USE CLEARLY MENTIONS THIS TYPE OF HAZARD AND HOW TO PREVENT IT FROM HAPPENING.