DXA 5000
Received May 18, 2021 · Event occurred Apr 22, 2021
Report 3006655511-2021-00002 · MDR key 11845882
Device
Generic name
Radioassay, Vitamin B12
Manufacturer
Beckman CoulterModel number
SER-RBUCatalog number
B87351
Product problems
- Patient Device Interaction Problem
- Patient Device Interaction Problem
Patient
Not reported
- Head Injury
- Head Injury
Narrative
Additional Manufacturer Narrative
THE FAILURE MODE IS DUE TO AN ACCIDENTAL INJURY. THE FSE RECEIVED IMMEDIATE TREATMENT TO THE WOUND AT THE ACCIDENT AND EMERGENCY DEPARTMENT IN HOSPITAL. NO ADDITIONAL MEDICATION WAS PRESCRIBED. THE FSE WAS MONITORED ON LIGHT DUTIES UPON HIS RETURN APPROXIMATELY 60 MINUTES AFTER THE INCIDENT. BECKMAN COULTER INTERNAL IDENTIFIER IS CASE-(B)(4). NO PATIENT DEMOGRAPHIC INFORMATION (AGE, WEIGHT, RACE OR ETHNICITY) WAS PROVIDED. (B)(6). DEVICE MANUFACTURING DATE NOT AVAILABLE.
Description of Event or Problem
WHILE INSTALLING A TRANSPORT SEGMENT OF THE DXA 5000 SYSTEM, THE FSE (FIELD SERVICE ENGINEER) SUSTAINED AN INJURY TO THE HEAD WHICH REQUIRED MEDICAL TREATMENT. PER THE INFORMATION PROVIDED, THE FSE INSTALLING A DXA TRACK SECTION BEHIND AN AU RBU, HIT HIS HEAD WHILST STANDING UP ON THE OPEN LID OF THE RBU. THIS CAUSED A 10CM GASH TO HIS HEAD REQUIRING THE CUT TO BE GLUED IN ACCIDENT AND EMERGENCY DEPARTMENT OF MAYO HOSPITAL. THE FSE RECEIVED IMMEDIATE TREATMENT TO THE WOUND AT THE ACCIDENT AND EMERGENCY DEPARTMENT IN HOSPITAL. NO ADDITIONAL MEDICATION WAS PRESCRIBED. THE FSE WAS MONITORED ON LIGHT DUTIES UPON HIS RETURN APPROXIMATELY 60 MINUTES AFTER THE INCIDENT.