PRECEDENCE

Additional Manufacturer Narrative

NOTE: PHILIPS HAS STARTED INVESTIGATING THIS EVENT. WE WILL FILE A FOLLOW-UP EMDR WHEN THE INVESTIGATION IS COMPLETE. INTERNAL CROSS REFERENCE: COMPLAINT (B)(4).

Description of Event or Problem

THIS COMPLAINT HAS BEEN EVALUATED BASED ON THE INFORMATION PROVIDED. IT WAS REPORTED THAT AFTER COMPLETING A CLINICAL SCAN, A PATIENT WAS TRANSFERRED FROM THE SCAN TABLE BACK TO THEIR WHEELCHAIR WITHOUT LOWERING THE TABLE TO ITS LOWEST POSITION, AS INSTRUCTED BY PHILIPS LABELING. WHEN THE PATIENT'S WHEELCHAIR WAS MOVED AWAY FROM THE SCANNER, THE LEFT PINKY FINGER (FIFTH DIGIT) OF THE PATIENT'S HAND WAS PINCHED IN A GAP AT THE BASE OF THE TABLE COVER. AS A RESULT, THE DISTAL PHALANX OF THE FINGER WAS SEVERED. AT THE TIME OF THE INCIDENT, THE SYSTEM WAS NOT IN USE, AND THE TABLE WAS STATIC; THE ONLY MOVEMENT WAS FROM THE PATIENT'S WHEELCHAIR. IT WAS NOTED THAT THE PATIENT HAD DIABETES, WHICH MAY HAVE AFFECTED THE SENSATION IN THEIR HANDS. THE PATIENT RECEIVED ANTIBIOTICS AND UNDERWENT SURGERY ON THE AFFECTED FINGER BUT HAS SINCE BEEN DISCHARGED. THIS ISSUE HAS BEEN DETERMINED TO BE A REPORTABLE EVENT BASED ON THE AVAILABLE INFORMATION. PHILIPS HAS INITIATED AN INVESTIGATION OF THIS COMPLAINT.

Additional Manufacturer Narrative

PHILIPS INVESTIGATED A COMPLAINT INVOLVING A PATIENT INJURY THAT OCCURRED FOLLOWING A CLINICAL SCAN ON A PRECEDENCE 6 SLICE CT SYSTEM. AFTER THE SCAN, THE PATIENT WAS TRANSFERRED FROM THE IMAGING COUCH BACK TO THEIR WHEELCHAIR. AT THE TIME, THE COUCH WAS STATIC AND HAD NOT BEEN LOWERED TO ITS LOWEST POSITION, AS PER PHILIPS¿ LABELING INSTRUCTIONS. WITHOUT ASSESSING THE PATIENT¿S CONDITION, THE CAREGIVER MOVED THE WHEELCHAIR AWAY FROM THE SCANNER. DURING THIS MOVEMENT, THE PATIENT¿S LEFT FIFTH DIGIT (PINKY FINGER) WAS PINCHED IN A GAP AT THE BASE OF THE TABLE COVER, RESULTING IN AN AMPUTATION OF THE DISTAL PHALANX. THE PATIENT¿S MEDICAL HISTORY INCLUDES CEREBRAL INFARCTION, DIABETES, STROKE, AND ALZHEIMER¿S DISEASE, WHICH MAY HAVE CONTRIBUTED TO REDUCED SENSATION IN THE HANDS AND DELAYED RECOGNITION OF THE INJURY. THE PATIENT RECEIVED ANTIBIOTICS AND UNDERWENT STUMP TRIMMING SURGERY BEFORE BEING DISCHARGED FROM CARE. THE INCIDENT WAS ESCALATED TO PHILIPS ENGINEERING FOR A TECHNICAL INVESTIGATION AND PRODUCT ANALYSIS. FINDINGS CONCLUDED THAT THE INJURY RESULTED FROM USE ERROR RATHER THAN DEVICE MALFUNCTION OR DESIGN DEFICIENCY. THE PATIENT INVOLVED IN THIS CASE HAS A PAST MEDICAL HISTORY OF CEREBRAL INFARCTION, DIABETES AND ALZHEIMER'S DISEASE, WHICH AFFECTED HIS SENSATION. THE PATIENT DID NOT FEEL THE INJURY, SO THEY DID NOT ASK FOR TIMELY HELP. THE CAREGIVER DIDN'T OBSERVE OR CHECK THE PATIENT¿S STATUS CAREFULLY BEFORE DIRECTLY PULLING THE PATIENT¿S WHEELCHAIR OUT FROM THE SCANNING ROOM. ADDITIONALLY, THE PRECEDENCE INSTRUCTIONS FOR USE (IFU) WERE REVIEWED AND FOUND TO CONTAIN SUFFICIENT WARNINGS AND PRECAUTIONS TO PREVENT SUCH INCIDENTS, INCLUDING: NEVER LEAVE A PATIENT UNOBSERVED BEFORE, DURING, OR AFTER A PROCEDURE. TO AVOID INJURY, NEVER LEAVE THE PATIENT UNOBSERVED IN THE SCAN ROOM. ADVISE PATIENTS NOT TO TOUCH ANY EXTERNAL APPARATUS. ENSURE THAT FINGERS, HAIR, CLOTHING, OR SHEETS DO NOT BECOME CAUGHT IN THE IMAGING TABLE. THE ON-SITE INVESTIGATION OF THE SYSTEM CONFIRMED THAT THE GAP BETWEEN COUCH BASE COVERS IS NOT ACCESSIBLE UNDER NORMAL CLINICAL WORKFLOW, AND THE HAZARDOUS SITUATION COULD ONLY OCCUR UNDER SPECIFIC AND INFREQUENT CONDITIONS. NO PRODUCT NONCONFORMANCE WAS IDENTIFIED, AND A THIRD PARTY FOR PRECEDENCE SPECT/CT NMPA REGISTRATION CONFIRMED THAT ALL TESTS PASSED, WITH NO GAP-RELATED NONCONFORMANCE'S OBSERVED. A PRECEDENCE PRODUCT FAMILY REVIEW FOUND NO OTHER REPORTED INJURIES OF THIS NATURE, INDICATING THAT THIS WAS AN ISOLATED EVENT. IN CONCLUSION, THE INJURY WAS ATTRIBUTED TO USE ERROR AND NOT A SYSTEM MALFUNCTION OR DESIGN DEFICIENCY.