AIRPAL

Additional Manufacturer Narrative

THE DESCRIBED SCENARIO WAS CONSIDERED POTENTIALLY RELATED TO PATIENT POSITIONING ON THE TRANSFER MATTRESS PRIOR TO ACTIVATION, RATHER THAN A CONFIRMED DEVICE MALFUNCTION. IMPROPER POSITIONING MAY CONTRIBUTE TO UNEVEN AIR DISTRIBUTION. THE INVESTIGATION IS ONGOING, AND RESULTS OF THE ANALYSIS WILL BE PROVIDED IN A FOLLOW-UP REPORT. NO UDI INFORMATION IS AVAILABLE, AS THE SERIAL NUMBER WAS NOT RECORDED BY THE CUSTOMER AT THE TIME OF THE EVENT. H3 OTHER TEXT: UNKNOWN DEVICE INVOLVED.

Description of Event or Problem

(B)(6) MEDICAL CENTER ((B)(6)) REPORTED CONCERNS REGARDING A PATIENT TRANSFER PERFORMED USING THE AIRPAL TRANSFER MATTRESS CONNECTED TO THE MAXI AIR PUMP. AN INITIAL ALLEGATION INDICATED THAT A PATIENT HAD ¿HIT THE FLOOR¿ DURING USE OF THE DEVICE. UPON FOLLOW-UP, THE CUSTOMER CLARIFIED THAT THE PATIENT DID NOT FALL TO THE FLOOR. THE REPORTED EVENT INVOLVED AN UNINTENTIONAL ROTATION OF A PATIENT FROM A SUPINE POSITION ONTO THE STOMACH WHILE ON A STRETCHER DURING USE OF THE AIRPAL DEVICE. THE EVENT OCCURRED AT THE INITIATION OF THE TRANSFER, WHEN THE MATTRESS WAS FIRST ACTIVATED AND BEGAN INFLATING. ACCORDING TO THE CUSTOMER, UNEVEN INFLATION OF THE MATTRESS WAS OBSERVED, WITH ONE SIDE INFLATING MORE RAPIDLY THAN THE OTHER, RESULTING IN PATIENT ROTATION BEFORE CLINICAL STAFF WERE ABLE TO STOP THE PUMP. THE CUSTOMER EXPRESSED A CONCERN REGARDING DEVICE DESIGN, SPECIFICALLY NOTING THE LACK OF STAGED OR CONTROLLED, EVEN INFLATION. NO PATIENT INJURY HAS BEEN REPORTED TO DATE. NO DEVICE MALFUNCTION HAS BEEN CONFIRMED AT THIS TIME.