POWER EXPRESS

Additional Manufacturer Narrative

A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) REPORTED THEY WERE WORKING ON POWER EXPRESS AUTOMATION INSTRUMENT, BENT OVER ON THEIR KNEES INSIDE THE MACHINE. THIS CAUSED THEM TO TWIST THEIR BACK AND LEFT KNEE GAVE OUT. THE FSE SOUGHT OUT MEDICAL ATTENTION DUE TO BACK AND KNEE PAIN. THE MEDICAL STAFF PRESCRIBED MUSCLE RELAXANTS TO ALLEVIATE THE PAIN, AND THEN REFERRED TO AN ORTHOPEDIST FOR FURTHER EVALUATION. THE ORTHOPEDIC VISITS ARE ONGOING, THE RECOMMENDED TREATMENT FOR BACK AND KNEE INJURY IS PHYSICAL THERAPY. NO PATIENT DEMOGRAPHIC INFORMATION (AGE, WEIGHT, RACE OR ETHNICITY) WAS PROVIDED. DEVICE MANUFACTURE DATE INFORMATION NOT AVAILABLE BECKMAN COULTER INTERNAL IDENTIFIER IS CASE (B)(4).

Description of Event or Problem

A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) REPORTED THEY SUSTAINED BACK KNEE AND BACK INJURY. THE FSE WAS ADJUSTING SENSOR ON THE POWER EXPRESS RECAPPED WHEN THEY EXPERIENCE PAIN IN THE BACK OF THEIR KNEE. THE FSE INDICATED THEY WERE KNEELING DOWN WHEN THEIR KNEECAP TWISTED CAUSING INJURY TO THEIR KNEE AND BACK. THE FSE SOUGHT OF MEDICAL ATTENTION, DUE TO THE INJURY. THE FSE WAS PRESCRIBED MUSCLE RELAXANTS TO ALLEVIATE THE PAIN. THE FSE WAS EVALUATED BY AN ORTHOPEDISTS, WHICH RECOMMENDED PHYSICAL THERAPY FOR KNEE AND BACK. THE FSE IS ON MEDICAL LEAVE.

Additional Manufacturer Narrative

SECTION D4: PENDING UDI INFORMATION FROM MANUFACTURING DATE. SECTION H4: MANUFACTURING DATE HAS BEEN REQUESTED FROM MANUFACTURE. WILL UPDATE ONCE THE INFORMATION IS RECEIVED.