VAC-PAC

Additional Manufacturer Narrative

THE CUSTOMER REPRESENTATIVE CONTACTED NATUS TECHNICAL SERVICE WHILE THE VAC-PAC WAS STILL UNDER THE PATIENT, SO THE LOT NUMBER AND AGE OF DEVICE WERE UNAVAILABLE DURING THE TIME OF THE INITIAL CALL. NATUS TECHNICAL SERVICE CONTACTED THE CUSTOMER ON 1/26/2018, 02/01/2018, 02/02/2018 AND 02/06/2018 FOR MORE INFORMATION AND FOR RETURN OF THE FAULTY UNIT. THE CUSTOMER REPORTED ON 02/06/2018 THAT THE VAC-PAC HAD BEEN DESTROYED ON (B)(6) 2018 AFTER THE SURGERY AND THAT THE VAC-PAC HAD NO VISIBLE DAMAGE. THE CUSTOMER WAS UNABLE TO PROVIDE LOT NUMBER OR DEVICE AGE. TECHNICAL SERVICE CONTINUED TO CONTACT THE CUSTOMER ON 02/12/2018 AND 02/15/2018. THESE ATTEMPTS TO CONTACT THE CUSTOMER WERE UNSUCCESSFUL. NATUS RECORDS SHOW THAT THE CUSTOMER ORDERED TWO VAC-PAC UNITS ON 2/5/2018. 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 THAT ARE USED SEVERAL TIMES A WEEK.

Description of Event or Problem

THE CUSTOMER CONTACTED NATUS TECHNICAL SERVICE TO REPORT A VAC-PAC THAT LOST SUCTION DURING SURGERY. THE CUSTOMER REPORTED THAT THE PATIENT WAS IN A LATERAL POSITION WHILE UNDERGOING A FOOT SURGERY WHEN THE VAC-PAC LOST SUCTION. SAFETY STRAPS WERE REPORTED TO BE USED ON THE PATIENT AS WELL. THE CUSTOMER REPORTED THAT THEY REPOSITIONED THE PATIENT, CONNECTED THE VAC-PAC TO CONTINUOUS SUCTION AND CONTINUED THE SURGERY. THE CUSTOMER DID REPORT A DELAY IN SURGERY, BUT NO PATIENT OR USER HARM HAS BEEN REPORTED.