EEG-1200A
Received Jan 4, 2019 · Event occurred Dec 11, 2018
Report 8030229-2019-00002 · MDR key 8220331
Device
Generic name
Neurofax Electroencephalograph
Manufacturer
Nihon Kohden CorporationModel number
EEG-1200ACatalog number
EEG-1200A
Lot number
NOT APPLICABLE
Product problems
- Mechanical Problem
- Mechanical Problem
Patient
Not reported
- No Consequences Or Impact To Patient
- No Known Impact Or Consequence To Patient
- No Consequences Or Impact To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
DETAILS OF COMPLAINT: CASTER FELL OFF CART. CUSTOMER CALLED BECAUSE ONE OF THE CASTERS ON THE CART CAME OFF. SHE HAD STATED THAT THE BOLT THAT HELD THE CASTER IN PLACE SHEERED AND CAUSED IT TO FALL OFF. NKA DOES NOT STOCK REPLACEMENT WHEELS. SERVICE REQUESTED: TROUBLESHOOTING. SERVICE PERFORMED: TROUBLESHOOTING. INVESTIGATION RESULT: TS HAS REACHED OUT TO THE CUSTOMER MULTIPLE TIMES REQUESTING MODEL NUMBER AND SN, INCLUDING A PICTURE. THIS INFORMATION WAS NOT PROVIDED BY THE CUSTOMER AND WAS EVENTUALLY TOLD THAT THE BIOMED WAS ABLE TO FIX THE CART. TS ASKED FOR THE CART INFORMATION AND SHE SAID SHE WAS UNABLE TO PROVIDE ME WITH THAT INFORMATION.
Description of Event or Problem
THE EEG TECH REPORTED THAT THE CASTER ON CART FOR THE EEG SYSTEM CAME OFF. THEY STATED THAT THE BOLT THAT HELD THE CASTER IN PLACE SHEERED ANDCAUSED IT TO FALL OFF. NO PATIENT HARM OR INJURY REPORTED.
Additional Manufacturer Narrative
DETAILS OF THE COMPLAINT ON (B)(6) 2018, CUSTOMER AT (B)(6) REPORTED THE CASTER ON THE EEG CART CAME OFF (EEG-1200A-RAID SN: (B)(6) ). THE BOLT THAT HELD THE CASTER IN PLACE SHEARED AND CAUSED IT TO FALL OFF. SERVICE REQUESTED: TROUBLESHOOTING/ASSISTANCE. SERVICE PERFORMED : CUSTOMER WAS ADVISED NKA DOES NOT STOCK CASTERS TO REPLACE ON CARTS. BME WAS ABLE TO FIX THE CART. CUSTOMER WAS UNABLE TO PROVIDE THE CART INFORMATION AFTER MULTIPLE FOLLOW UP ATTEMPTS FROM NKA TS. INVESTIGATION RESULT CART INFORMATION WAS UNAVAILABLE. DETAILS SURROUNDING THE INCIDENT, INCLUDING PICTURES OF THE CASTER, WAS NOT PROVIDED. CUSTOMER WAS ABLE TO RESOLVE THE ISSUE INTERNALLY WITHOUT NKA ASSISTANCE. EEG WARRANTY BEGAN 10/28/2015. THE ISSUE OCCURRED AFTER 3 YEARS AT CUSTOMER FACILITY. REVIEW OF EEG SAP HISTORY FOUND NO REPORTED ISSUES WITH THE UNIT. BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, INVESTIGATION IS LIMITED AND THE ROOT CAUSE COULD NOT BE DETERMINED. THE ISSUE INVOLVED CONDITION OF THE PHYSICAL EEG CART AND THERE WAS NO REPORTED ISSUE WITH FUNCTIONALITY OF THE EEG SYSTEM. REVIEW OF TICKETS OPENED AT (B)(6) FOUND NO ADDITIONAL ISSUES REPORTED RELATING TO "CASTER". INVESTIGATION CONCLUSION: BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, INVESTIGATION IS LIMITED AND THE ROOT CAUSE COULD NOT BE DETERMINED. THE ISSUE INVOLVED CONDITION OF THE PHYSICAL EEG CART AND THERE WAS NO REPORTED ISSUE WITH FUNCTIONALITY OF THE EEG SYSTEM. REVIEW OF TICKETS OPENED AT (B)(6) HOSPITAL FOUND NO ADDITIONAL ISSUES REPORTED RELATING TO "CASTER".
Additional Manufacturer Narrative
THE EEG TECH REPORTED THAT THE CASTER ON CART FOR THE EEG SYSTEM CAME OFF. THEY STATED THAT THE BOLT THAT HELD THE CASTER IN PLACE SHEERED AND CAUSED IT TO FALL OFF. NO PATIENT HARM OR INJURY REPORTED. NIHON KOHDEN CONTINUES TO INVESTIGATE THE REPORTED EVENT. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
THE EEG TECH REPORTED THAT THE CASTER ON CART FOR THE EEG SYSTEM CAME OFF. THEY STATED THAT THE BOLT THAT HELD THE CASTER IN PLACE SHEERED AND CAUSED IT TO FALL OFF. NO PATIENT HARM OR INJURY REPORTED.