LAERDAL SUCTION UNIT

Additional Manufacturer Narrative

LAERDAL REQUESTED THAT THE DEVICE WAS RETURNED TO THE TECHNICAL CENTER FOR EVALUATION, BUT DESPITE FOLLOW UPS BETWEEN OCTOBER 2025 AND JANUARY 2026, THE UNIT WAS NEVER RECEIVED. THE CASE WAS CLOSED AFTER MULTIPLE ATTEMPTS TO CONTACT THE CUSTOMER.NO FAILURE SYMPTOMS COULD BE VERIFIED, AS NO SAMPLE WAS RECEIVED AND THE CUSTOMER DID NOT RESPOND DESPITE MULTIPLE CONTACT ATTEMPTS. BASED ON THE COMPLAINT DESCRIPTION, THE DEVICE REPORTEDLY PASSED FUNCTIONAL TESTING PRIOR TO USE; HOWEVER, A LOSS OF SUCTION OCCURRED DURING CLINICAL APPLICATION. THE UNIT WAS MANUFACTURED IN 2004. NO CORRECTIVE ACTIONS WERE DEEMED NECESSARY. THE DEVICE WAS OUTSIDE ITS EXPECTED LIFETIME AT THE TIME OF THE EVENT. THE EXPECTED SERVICE LIFE OF THE DEVICE IS 10 YEARS CONTINGENT ON FOLLOWING SERVICE GUIDELINES DETAILED IN THE INSTRUCTIONS FOR USE.

Additional Manufacturer Narrative

INVESTIGATION REMAINS OPEN PENDING RETURN OF AFFECTED DEVICE. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

ON 10/16/2025, A NURSE IN CANADA REPORTED TO LAERDAL THAT SHE ATTEMPTED TO USE THE LSU WITH A REUSABLE CANISTER, BUT THE SUCTION WAS NOT WORKING. SHE THEN USED A SECOND DEVICE, AND IT WORKED. NO PATIENT HARM WAS CONFIRMED. A PATIENT EVENT QUESTIONNAIRE WAS SENT BY LAERDAL'S HELPDESK, WITH MULTIPLE FOLLOW-UP ATTEMPTS MADE WITHOUT RESPONSE. THE UNIT WAS IDENTIFIED AS MANUFACTURED IN 2004 AND OUT OF WARRANTY. ON 11/20/2025, A PATIENT EVENT QUESTIONNAIRE COMPLETED BY A CLINICAL ENGINEER FROM NORTHERN HEALTH AUTHORITY, ON BEHALF OF THE FACILITY WHERE THE EVENT OCCURRED, (B)(6), AS SENT BACK TO (B)(6). IT CLARIFIED THAT THE INCIDENT INVOLVED A PATIENT WHO WAS CHOKING; A NURSE ATTEMPTED TO USE THE DEVICE, BUT IT DID NOT GENERATE ENOUGH VACUUM TO CLEAR THE PATIENT'S AIRWAY. ANOTHER DEVICE WAS THEN USED. THEY CONFIRMED THE FIRST UNIT WAS REMOVED FROM SERVICE. (B)(6) HELPDESK FOLLOWED UP AND REQUESTED THAT THE UNIT BE RETURNED FOR EVALUATION. ON 12/2/2025, THE HELPDESK SENT THE CUSTOMER ANOTHER FOLLOW-UP EMAIL WITH RETURN INSTRUCTIONS AND SHIPPING LABELS. ON 12/10/2025, AN UPDATED PATIENT EVENT QUESTIONNAIRE, COMPLETED BY THE SAME CLINICAL ENGINEER, WAS SENT TO LAERDAL. IT CLARIFIED THAT THE CAUSE OF DEATH IS STILL UNKNOWN AND THAT THE FACILITY WHERE THE REPORTER WORKS HAS NOT YET RECEIVED AN AUTOPSY REPORT. THEY ALSO CONFIRMED THE PATIENT HAD PREEXISTING CONDITIONS AND WAS TAKING MEDICATION AT THE TIME OF THE ALLEGED INCIDENT. IT WAS FURTHER CONFIRMED THAT THERE WAS NO SIGNIFICANT DELAY BETWEEN SWITCHING DEVICES, THE INITIAL LSU UNIT PASSED THE DEVICE TEST PRIOR TO USE, AND NO ISSUES WERE NOTICED OR REPORTED FOR THE BACKUP UNIT. AS OF 12/18/2025, (B)(6) HAS NOT YET RECEIVED THE DEVICE FOR INVESTIGATION, AND THE INVESTIGATION RELATED TO THIS INCIDENT REMAINS OPEN.