MALIBU/SOVEREIGN (INCL. DIGNITY)

Additional Manufacturer Narrative

(B)(4). WHEN REVIEWING SIMILAR REPORTABLE EVENTS FOR MALIBU/SOVEREIGN (INCL. DIGNITY) WE HAVE FOUND NUMBER OF OTHER SIMILAR CASES WHERE SEAT DETACHED FROM LIFTING UNIT AND DROPPED. WE HAVE BEEN ABLE TO ESTABLISH THAT THERE IS STABLE COMPLAINT TREND CONCERNING THESE KIND OF EVENTS. ARJOHUNTLEIGH MANUFACTURED OVER (B)(4) MALIBU/SOVEREIGN (INCL. DIGNITY) BATHS TO DATE. WITH THE AMOUNT OF SOLD DEVICES AND WITH COMPARISON TO THE DAILY USE OF THEM, THE TREND OBSERVED FOR COMPLAINTS WITH THIS FAILURE MODE IS CONSIDERED TO BE VERY LOW AND ACCEPTABLE. THE DEVICE WAS INSPECTED BY AN ARJOHUNTELIGH REPRESENTATIVE AT THE CUSTOMER SITE AND FOUND TO BE OUT OF SPECIFICATION. THE DEVICE WAS BEING USED FOR PATIENT HANDLING AND IN THAT WAY CONTRIBUTED TO THE EVENT. FROM THIS WE CONCLUDE THAT THIS INCIDENT WAS CAUSED AS A RESULT OF STAFF INCORRECTLY TRAINED, NOT FOLLOWING THE PATIENT HANDLING PROCEDURES AS INDICATED IN THE INSTRUCTIONS FOR USE OF THE DEVICE AND INCORRECTLY PERFORMED PREVENTIVE MAINTENANCE. THE RECEIVED INFORMATION AND OUR EVALUATION AS DESCRIBED ABOVE ARE SHOWING THAT IF THE MALIBU'S TRANSFER PROCEDURES WERE FOLLOWED IN ACCORDANCE TO INSTRUCTION FOR USE AND PREVENTIVE MAINTENANCE HAS BEEN CORRECTLY PERFORMED THERE WILL BE NO PATIENT OR CAREGIVER AT RISK. WE HAVE NOT BEEN ABLE TO FIND ANY CONTRIBUTING MANUFACTURING ANOMALIES.

Description of Event or Problem

(B)(4).