AMBU PERFIT ACE COLLAR

Additional Manufacturer Narrative

THE COLLAR WAS SENT BACK TO THE MANUFACTURING SITE (AMBU INNOVATION SDN BHD) FOR INSPECTION. IT WAS VERIFIED THAT EXTRA VELCRO HOOK FOR THIN NECKS HAD DETACHED, AS THE SMALL VELCRO HOOK HAD DETACHED FROM THE PANEL OF PERFIT ACE COLLAR, AND NOW ADHERED TO THE BLUE VELCRO LOOP INSTEAD. THE ADHESIVE OF THE VELCRO HOOK REMAINED ON THE PANEL, INDICATING AN ISSUE WITH THE ADHESIVE STRENGTH AS THE REASON FOR THE DETACHMENT. HOWEVER, THE INSPECTION RESULTS PROVIDED BY THE SUPPLIER FOR THE SMALL VELCRO HOOK, INDICATE THE SMALL VELCRO HOOK MEET THE ADHESIVE REQUIREMENTS, THUS THE MALFUNCTION SHOULD NOT BE DUE TO COMPONENT PROBLEMS. THE MALFUNCTION IS NEITHER DUE TO MANUFACTURING ISSUES, AS THERE WAS NOT DIRT ON THE PANEL, THAT COULD HAVE WEAKENED THE ADHESION FORCE. DUE TO THE ABOVE REASONS WE ARE UNABLE TO ESTABLISH THE ROOT CAUSE FOR THE MALFUNCTION.. . THE SMALL VELCRO HOOK IS DESIGNED TO PROVIDE COMPLETE FIXATION, WHEN THE COLLAR IS USED ON A PATIENT WITH THIN NECK. AS THERE IS ANOTHER BIG VELCRO HOOK ON THE PANEL, WHICH IS THE MAIN PART FOR FIXATION OF THE COLLAR, THE COLLAR IS STILL ABLE TO PROVIDE NECK SUPPORT, BUT WILL BE UNABLE TO PROVIDE COMPLETE FIXATION ON PATIENTS WITH THIN NECKS. THIS IS THE FIRST COMPLAINT DURING THE PAST 36 MONTHS AND THE COMPLAINT RATE IS LOW. THE RISK OF DETACHMENT OF THE VELCRO, HAS BEEN EVALUATED IN THE PRODUCT RISK ASSESSMENT, AND THE RISK TO THE PATIENT IS CONCLUDED TO BE ACCEPTABLE LOW. CONSIDERING THE LOW COMPLAINT RATE, THIS IS CONSIDERED AN ISOLATED CASE. SINCE THE ROOT CAUSE IS NOT DETERMINED, CORRECTIVE ACTION IS NOT AVAILABLE.

Description of Event or Problem

DURING USE, THE OPERATOR FOUND THAT FOR PERFIT ACE COLLAR, THE EXTRA VELCRO FOR ADJUSTING TO A THIN NECK HAD DETACHED, PREVENTING IT FROM SECURING THE NECK COMPLETELY. THE FAULTY PRODUCT DID NOT RESULT IN ANY PATIENT HARM.