CENTURY

Description of Event or Problem

ARJOHUNTLEIGH RECEIVED A CUSTOMER COMPLAINT WHERE IT WAS REPORTED THAT DURING A BATH TWO YEARS AGO THE RESIDENT WAS ELECTROCUTED. SHE LET OUT A SCREECH AND CONTINUED WITH THE BATH. FEW DAYS AFTER EVENT THE RESIDENT STARTED TO FELL SYMPTOMS WHICH WERE ALLEGED TO BE THE RESULT OF THE SHOCK. THE SYMPTOMS WERE DESCRIBED AS: TINGLING THROUGHOUT THE BODY, SENSE OF IMBALANCE, RINGING IN THE EARS, PAIN TRAVELLING UP AND DOWN THE SPINE, GREAT PAIN IN THE KNEES AND ARMS, CONSTANT HEADACHES, SPEECH DIFFICULTIES, DAY AND NIGHT SWEATS (HOT AND COLD) AND HEART PALPITATIONS. THERE IS NO INDICATION THAT ANY TREATMENT WAS DELIVERED AS A RESULT OF THIS EVENT. THE FACILITY WAS VISITED TO GATHER MORE INFORMATION AND EXAMINE THE DEVICE. THERE IS NO EVIDENCE OR KNOWLEDGE THAT AN INCIDENT OCCURRED, CENTURY TUB IS IN EXCELLENT CONDITION AND CORRECT WORKING ORDER.

Additional Manufacturer Narrative

THIS REPORT IS BEING FILED UNDER EXEMPTION E2012070 BY ARJOHUNTLEIGH POLSKA SP. Z O.O. (REGISTRATION#3007420694) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH, INC. (AHUS) (REGISTRATION#1419652). PLEASE NOTE THAT PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MANUFACTURING SITE ARJO HOSPITAL EQUIPMENT AB LTD (UNDER REGISTRATION #9611530). AS OF 2014 THAT NUMBER WAS DE-ACTIVATED DUE TO THE SITE NO LONGER SHIPPING PRODUCT TO THE USA. FROM 2014 AND GOING FORWARD COMPLAINTS RELATED TO THESE PRODUCTS ARE TO BE HANDLED BY ARJOHUNTLEIGH AB'S COMPLAINT HANDLING ESTABLISHMENT AND ANY MEDWATCH REPORTS WILL BE SUBMITTED UNDER REGISTRATION #3007420694. AN INVESTIGATION WAS CARRIED OUT INTO THIS COMPLAINT. WHEN REVIEWING SIMILAR REPORTABLE EVENTS FOR CENTURY WE HAVE FOUND NO OTHER SIMILAR CASE WHERE ELECTRICAL SHOCK OCCURRED OR WAS ALLEGED, THEREFORE WE CONSIDER THIS CASE AS ISOLATED. IT WAS ALLEGED BY THE PATIENT THAT DURING A BATH SESSION TWO YEARS BEFORE, SHE FELT ELECTRICAL SHOCK, WHAT RESULTED IN MULTIPLE SYMPTOMS, WHICH ALLEGEDLY BECAME WORSE AFTER TIME. THE FACILITY STATED THAT THERE IS NO EVIDENCE OR KNOWLEDGE THAT ANY INCIDENT OCCURRED. ARJOHUNTLEIGH'S REPRESENTATIVE WHO PERFORMED DEVICE EXAMINATION CONFIRMED THAT THE DEVICE WAS UP TO MANUFACTURER'S SPECIFICATION. A CLINICAL EXPERT, WHO WAS ASKED TO ASSESS SEVERITY OF THE HARM, STATED THAT IT APPEARS ODD THAT THE PATIENT DID NOT GET A COMPLETE WORK UP IF SHE WAS ACTUALLY SHOCKED. THE FACT THAT SHE CONTINUED HER BATH AND THE NURSE WAS NOT CONCERNED ALSO APPEARS OUT OF LINE WITH AN ACTUAL ELECTRICAL SHOCK SITUATION. UNFORTUNATELY, THE ARJOHUNTLEIGH REPRESENTATIVE WHO HAS BEEN TRYING TO CONTACT THE COMPLAINANT IN ORDER TO OBTAIN MORE INFORMATION FROM A MEDICAL PROFESSIONAL WHO EXAMINED THE PERSON INVOLVED, OR OTHER RELEVANT PERSONS RELATED TO THE EVENT SUCH AS CAREGIVERS, WITHOUT SUCCESS. AN ASSESSMENT OF WHAT IS BEING CLAIMED COULD NOT BE PERFORMED WITHOUT ANY FURTHER EVIDENCE. IN CONCLUSION, NO MALFUNCTION OF THE BATH WAS FOUND. IT WAS USED FOR PATIENT'S CARE AND THIS WAY CONTRIBUTED TO ALLEGED EVENT. HAVING THAT CONTRADICTORY INFORMATION WE CANNOT CONFIRM THE EVENT OCCURRENCE, ESTABLISH EXACT SCENARIO OF EVENTS OR ROOT CAUSE OF THE INJURIES. IN CASE ANY ADDITIONAL INFORMATION BECOME AVAILABLE IN THE FUTURE, THE INVESTIGATION WILL BE UPDATED.