LAERDAL SUCTION UNIT
Received Sep 11, 2025 · Event occurred Aug 13, 2025
Report 3002807435-2025-00001 · MDR key 23029462
Device
Generic name
Emergency Airway Clearance Suction System, Electric
Manufacturer
Laerdal Medical A/sCatalog number
78002001
Product problems
- Electrical /Electronic Property Problem
- Failure to Run on Battery
- Battery Problem
- Suction Failure
- Electrical /Electronic Property Problem
- Failure to Run on Battery
- Battery Problem
- Suction Failure
Patient
NA · Unknown
- Airway Obstruction
- Insufficient Information
- Airway Obstruction
- Insufficient Information
Narrative
Description of Event or Problem
AN EMS CUSTOMER REPORTED THAT A LAERDAL SUCTION UNIT (LSU) WITH A BEMIS CANNISTER FAILED TO SUCTION WHILE OPERATING ON BATTERY POWER DURING TREATMENT OF A PATIENT UNABLE TO BREATHE. THE UNIT FUNCTIONED WHEN PLUGGED IN, BUT NOT ON BATTERY POWER. THE PATIENT DIED DURING THE EVENT. THE INCIDENT OCCURRED IN THE U.S. LAERDAL IS INVESTIGATING AND HAS REQUESTED A COMPLETED PATIENT QUESTIONNAIRE AND RETURN OF THE DEVICE FOR EVALUATION. AS OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED REGARDING THE INCIDENT, THE BATTERY USED, DEVICE SERVICING, OR PRE-USE DEVICE TESTING.
Additional Manufacturer Narrative
IN ACCORDANCE WITH 21 CFR §803.56 AND FDA MDR GUIDANCE ON FOLLOW-UP REPORTING, LAERDAL HAS MADE GOOD-FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION RELATED TO THIS EVENT. EIGHT DOCUMENTED OUTREACH ATTEMPTS THROUGH PHONE AND EMAIL WERE MADE BY LAERDAL WITHOUT RESPONSE FROM THE COMPLAINANT. IT IS THEREFORE NOT POSSIBLE TO CONFIRM THE EXACT FAILURE OF THE PRODUCT. BASED ON THE INITIAL CUSTOMER COMPLAINT, IT IS LIKELY THAT THE BATTERY WAS NOT WORKING. IT IS UNKNOWN HOW OLD THE BATTERY WAS AT THE TIME OF INCIDENT. BATTERY PERFORMANCE IS DEPENDENT ON AGE, USE AND CHARGING REGIME. IT IS LIKELY THAT THE CUSTOMER HAS NOT PERFORMED THE BATTERY TEST AS DESCRIBED IN USER GUIDE. ALTERNATIVE SUCTION METHODS ARE AVAILABLE TO THE CLINICIAN IN THE CASE OF DEVICE FAILURE. DELAY OF SUCTION TREATMENT IS CONSIDERED TO HAVE LOW SEVERITY.
Description of Event or Problem
AN EMS CUSTOMER REPORTED THAT A LAERDAL SUCTION UNIT (LSU) WITH A BEMIS CANNISTER FAILED TO SUCTION WHILE OPERATING ON BATTERY POWER DURING TREATMENT OF A PATIENT UNABLE TO BREATHE. THE UNIT FUNCTIONED WHEN PLUGGED IN, BUT NOT ON BATTERY POWER. THE PATIENT DIED DURING THE EVENT. THE INCIDENT OCCURRED IN THE U.S. LAERDAL IS INVESTIGATING AND HAS REQUESTED A COMPLETED PATIENT QUESTIONNAIRE AND RETURN OF THE DEVICE FOR EVALUATION. AS OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED REGARDING THE INCIDENT, THE BATTERY USED, DEVICE SERVICING, OR PRE-USE DEVICE TESTING.