MALIBU/SOVEREIGN (INCL. DIGNITY)

Additional Manufacturer Narrative

(B)(6). WHEN REVIEWING SIMILAR REPORTABLE EVENTS FOR MALIBU/SOVEREIGN (INCL. DIGNITY) WE HAVE FOUND A LOW NUMBER SIMILAR CASES. WE HAVE BEEN ABLE TO ESTABLISH THAT THERE IS AN INCREASING BUT VERY LOW COMPLAINT TREND CONCERNING THESE KIND OF EVENTS. ARJOHUNTLEIGH MANUFACTURED OVER (B)(4) (INCL. DIGNITY) BATHS TO DATE. WITH THE NUMBER OF SOLD DEVICES AND COMPARED TO DAILY USE OF THE BATHS, THE TREND OBSERVED FOR COMPLAINTS WITH THIS FAILURE MODE IS CONSIDERED TO BE VERY LOW AND ACCEPTABLE. THE DEVICE WAS INSPECTED BY AN ARJOHUNTLEIGH REPRESENTATIVE AT THE CUSTOMER SITE AND FOUND TO BE OUT OF THE SPECIFICATION. THE DEVICE WAS BEING USED FOR PT HANDLING WHICH CONTRIBUTED TO THE EVENT. WE HAVE NOT BEEN ABLE TO FIND ANY CONTRIBUTING MANUFACTURING ANOMALIES. FROM ABOVE FINDINGS WE CONCLUDE THAT THIS INCIDENT WAS CAUSED BY USER ERROR - INCORRECT RE-INSTALLATION OF THE DEVICE AND POOR MAINTENANCE. THE RECEIVED INFORMATION AND OUR EVALUATION AS DESCRIBED ABOVE ARE SHOWING THAT IS MALIBU'S INSTALLATION PROCEDURES WERE FOLLOWED IN ACCORDANCE TO ASSEMBLY ADN INSTALLATION INSTRUCTIONS AND MAINTENANCE WERE FOLLOWED IN ACCORDANCE TO PREVENTIVE MAINTENANCE SCHEDULE, THERE WOULD BE NO PT OR CAREGIVER AT RISK.

Description of Event or Problem

(B)(4).