CLASSIC LINE 2

Additional Manufacturer Narrative

THE DEVICES WERE NOT MADE AVAILABLE FOR AN IN-DEPTH EVALUATION BY ARJO. NO CLASSIC LINE 2 FAILURE WAS CLAIMED IN THE COMPLAINT TO ARJO. THE DETAILS CONCERNING THE CLAIMED EVENT WERE NOT DISCLOSED DUE TO THE INITIATED POLICE INVESTIGATION. THE INSTRUCTIONS FOR USE DEDICATED TO MAXI SKY 2 (IFU 001-15698-EN) CONTAINS THE GENERAL PROCEDURE FOR TRANSFERRING THE PATIENT FROM A SEATED OR SUPINE POSITION. AS PER THE IFU THE PATIENT CAN BE TRANSFERRED USING MAXI SKY 2 ¿TO OR FROM ADJACENT LOCATION SUCH AS CHAIR, WHEELCHAIR, BED, BATH, TOILET, FLOOR, OR STRETCHER.¿ ADDITIONALLY, THE IFU STATES: - ¿THE TECHNIQUES DESCRIBED HERE CAN BE USED FOR TRANSFERRING PATIENTS REGARDLESS OF WHERE THEY MAY BE SEATED (E.G. IN A BED, IN A CHAIR, WHEELCHAIR OR SIMILAR). - ¿THE TECHNIQUES DESCRIBED HERE CAN BE USED FOR TRANSFERRING PATIENTS REGARDLESS OF WHERE THEY MAY BE LAYING (ON THE BED OR ON THE FLOOR OF THE EXERCISE AREA).¿ IT IS ALSO MENTIONED THAT THERE IS A LABEL ON THE SPREADER BAR THAT "SIGNIFIES THAT ANYTHING ABOVE ITS POSITION MUST NOT BE SOAKED IN WATER, EITHER WHEN BATHING OR SHOWERING THE PATIENT." BASED ON THIS, IT CAN BE CONCLUDED THAT FOLLOWING THE STEPS IN THE INSTRUCTIONS FOR USE DEDICATED TO MAXI SKY 2 ALLOWS FOR THE SAFE TRANSFER OF THE PATIENT TO THE BATH. ADDITIONALLY, THE INSTRUCTIONS FOR USE DEDICATED TO CLASSIC LINE 2 BATH (04.ACL.00_5EN) WARNS: "TO AVOID INJURY OR STRANGULATION, MAKE SURE THAT THE PATIENT IS NOT LEFT UNATTENDED AT ANY TIME". IN THE REPORTED EVENT, THE DISABLED PATIENT WAS ALLEGEDLY LEFT UNATTENDED WHICH IS INCONSISTENT WITH THE IFU. TO SUM UP, ARJO DEVICES WERE USED WITH THE PATIENT WHEN THE EVENT OCCURRED. CURRENTLY, ARJO IS NOT AWARE OF ANY DEVICE MALFUNCTION THAT COULD CONTRIBUTE TO THE EVENT. THE REPORTED EVENT IS A SINGULAR OCCURRENCE. THE COMPLAINT DECIDED TO BE REPORTABLE AS THE PATIENT PASSED AWAY WHILE USING ARJO DEVICES. H3 OTHER TEXT : NOT AVAILABLE FOR IN DEPTH EVALUATION.

Description of Event or Problem

ARJO WAS INFORMED ABOUT AN EVENT THAT OCCURRED WHILE USING A MAXI SKY 2 CEILING LIFT AND CLASSIC LINE 2 BATH. AFTER LOWERING THE PATIENT INTO THE BATH USING THE CEILING LIFT, THE PATIENT WAS ALLEGEDLY LEFT UNATTENDED. THE PATIENT WHO WAS MENTALLY AND PHYSICALLY DISABLED PERSON DROWNED IN THE BATHTUB. (AS TWO ARJO DEVICES WERE INVOLVED, TWO SEPARATE INCIDENT REPORTS WERE SUBMITTED. THIS ONE REFERS TO THE INVOLVED CLASSIC LINE 2 BATH. THE REPORT FOR MAXI SKY 2 CEILING LIFT IS SUBMITTED UNDER THE MANUFACTURER'S REFERENCE NUMBER: (B)(4).)

Additional Manufacturer Narrative

THE PROCESS OF GATHERING INFORMATION IS ONGOING. THE RESULTS WILL BE PROVIDED TO THE FOLLOW-UP REPORT.

Description of Event or Problem

ARJO WAS INFORMED ABOUT THE EVENT WITH THE PARTICIPATION OF THE MAXI SKY 2 CEILING LIFT AND CLASSIC LINE 2 BATH. AFTER LOWERING THE PATIENT TO THE BATH, THE PATIENT WAS LEFT UNATTENDED. THE PATIENT WHO WAS MENTALLY AND PHYSICALLY DISABLED PERSON DROWNED IN THE BATHTUB. NO MALFUNCTION OF ARJO DEVICES THAT COULD CONTRIBUTED TO THIS EVENT WAS CURRENTLY IDENTIFIED. THIS REPORT IS RELATED TO INVOLVED CLASSIC LINE 2 BATH. THE REPORT FOR MAXI SKY 2 IS SUBMITTED UNDER MANUFACTURER'S REFERENCE NUMBER: 9681684-2023-00077.