VAC-PAC

Additional Manufacturer Narrative

THE CUSTOMER WAS PROVIDED INFORMATION FOR STORAGE, REPAIR, TESTING AND REPLACEMENT. NATUS TECHNICAL SERVICE ADVISED THE USER THAT THE VAC-PAC IFU NOTES TO CHOOSE A VAC-PAC THAT SUPPORTS THE PATIENT AND TO USE ADDITIONAL SUPPORTS AS NEEDED. USERS ARE INSTRUCTED TO CHECK THE VAC-PAC DEVICE BEFORE AND AFTER EACH USE AND NOT TO USE THE DEVICE IF THERE IS KNOWN DAMAGE OR A LEAK. USERS ARE ALSO INSTRUCTED TO REPLACE UNITS OLDER THAN TWO YEARS.

Description of Event or Problem

IT WAS REPORTED TO NATUS THAT A VAC-PAC LOST SUCTION DURING A SURGICAL PROCEDURE WHILE CONNECTED TO CONTINUOUS SUCTION. UPON LOSS OF SUCTION, THE PATIENT BEGAN SLIDING OFF OF THE OPERATING ROOM TABLE. THE ANESTHESIOLOGIST WAS ABLE TO STOP THE PATIENT'S SLIDE. THERE WAS NO HARM CAUSED TO THE PATIENT. IT WAS NOT REPORTED WHETHER THERE WAS ANY VISIBLE DAMAGE TO THE VAC-PAC. THE VAC-PAC WAS REPORTED TO HAVE BEEN PURCHASED OVER TWO YEARS PRIOR TO THE DATE OF THE EVENT.