VAC-PAC

Additional Manufacturer Narrative

THE SUSPECTED VAC-PAC WAS RETURNED BACK TO NATUS FOR EVALUATION ON 04/24/2019, NATUS PERFORMED THE TESTING AND FAILURE COULD NOT BE DUPLICATED. VAC-PAC DID NOT LOOSE VACUUM, REMAINED FIRM FOR 24 HOURS. NO VISIBLE DAMAGE.

Additional Manufacturer Narrative

THE VAC-PAC LOSS OF SUCTION DESCRIBES A MALFUNCTION. THE CUSTOMER HAS REPORTED THAT THE VAC-PAC MALFUNCTIONED DURING A SURGICAL PROCEDURE, NOT DURING SURGICAL PREPARATIONS. NATUS MEDICAL REQUESTED CUSTOMER TO SEND THE SUSPECTED VAC-PAC BACK FOR EVALUATION, AND IF ADDITIONAL INFORMATION BECOMES AVAILABLE NATUS WILL FILE A SUPPLEMENTAL REPORT.

Description of Event or Problem

NATUS TECHNICAL SERVICE WAS NOTIFIED OF AN EVENT THAT OCCURRED ON (B)(6) 2019 WHEN A NATUS SIZE 32 VAC-PAC, LOT NUMBER: N081417-07 LOST SUCTION WHILE IN USE ON A PATIENT UNDERGOING SHOULDER ROTATOR CUFF REPAIR SURGERY. THE CUSTOMER ALSO STATED THAT THE LOSS OF SUCTION RESULTED IN MOVEMENT OF THE PATIENT'S POSITION. THE PATIENT CARE PROVIDERS WERE DELAYED SLIGHTLY AS THEY WERE REQUIRED TO USE OTHER MATERIALS TO REPOSITION THE PATIENT. NO INJURY WAS REPORTED AS A RESULT OF THE EVENT. ON (B)(4) 2019 NATUS REQUESTED ADDITIONAL INFORMATION RELATED TO THE NATURE OF THE EVENT AND STATUS OF THE PATIENT AFTER THE SURGERY. THE CUSTOMER HAS NOT RESPONDED. A REPLACEMENT DEVICE WAS SHIPPED TO THE CUSTOMER AND THE CUSTOMER WAS ASKED TO RETURN THE MALFUNCTIONING PRODUCT FOR EXAMINATION AND TESTING. NO DEATH, SERIOUS INJURY, PATIENT HARM OR ENVIRONMENTAL/SAFETY CONCERNS HAVE BEEN REPORTED.