DYNAMIC INLET, PLC (BULK READY), POWER EXPRESS
Received Aug 29, 2019 · Event occurred Jan 19, 2018
Report 2050012-2019-01101 · MDR key 8945310
Device
Generic name
Radioassay, Vitamin B12
Manufacturer
Beckman CoulterModel number
DYNAMIC INLET, PLC (BULK READY), POWER EXPRESSCatalog number
B90918
Product problems
- Adverse Event Without Identified Device or Use Problem
- Device Handling Problem
- Adverse Event Without Identified Device or Use Problem
- Device Handling Problem
Patient
Not reported
- Injury
- Injury
Narrative
Additional Manufacturer Narrative
NO PATIENT INVOLVEMENT. BECKMAN COULTER FSE REPORTED THAT HE SUSTAINED AN INJURY WHILE PERFORMING A POWER EXPRESS SYSTEM INSTALLATION. FSE STATED THAT WHILE SETTING UP A MODULE HE WAS IN AN AWKWARD POSITION BEFORE GETTING TO A FINAL POSITION. FSE WENT ON MEDICAL LEAVE OF ABSENCE FOR APPROXIMATELY EIGHT (8) WEEKS AND WAS ON WORKMAN¿S COMPENSATION. EVIDENCE SUGGESTS THAT THE EVENT WAS DUE TO USE ERROR SINCE TRAINING HAS BEEN PROVIDED TO FSE ON HOW TO AVOID ERGONOMIC RISKS, INCLUDING BUT NOT LIMITED TO AWKWARD BODY POSTURES AND REPETITIVE MOTIONS. THERE IS NO EVIDENCE OF A SYSTEM OR HARDWARE MALFUNCTION. THE FAILURE MODE WAS CONFIRMED TO BE CUSTOMER USE ERROR. (B)(4).
Description of Event or Problem
BECKMAN COULTER FSE REPORTED THAT HE SUSTAINED AN INJURY WHILE PERFORMING A POWER EXPRESS SYSTEM INSTALLATION. FSE STATED THAT WHILE SETTING UP A MODULE HE WAS IN AN AWKWARD POSITION BEFORE GETTING TO A FINAL POSITION. FSE WENT ON MEDICAL LEAVE OF ABSENCE FOR APPROXIMATELY EIGHT (8) WEEKS AND WAS ON WORKMAN¿S COMPENSATION. EVIDENCE SUGGESTS THAT THE EVENT WAS DUE TO USE ERROR SINCE TRAINING HAS BEEN PROVIDED TO FSE ON HOW TO AVOID ERGONOMIC RISKS, INCLUDING BUT NOT LIMITED TO AWKWARD BODY POSTURES AND REPETITIVE MOTIONS. THERE IS NO EVIDENCE OF A SYSTEM OR HARDWARE MALFUNCTION.