LAERDAL COMPACT SUCTION UNIT 4

Additional Manufacturer Narrative

THE INVESTIGATION CONCLUDED THAT BOTH LCSU4 UNITS WERE EQUIPPED WITH BATTERIES MORE THAN 5-6 YEARS OLD, FAR EXCEEDING THE USER GUIDE RECOMMENDATION TO REPLACE BATTERIES EVERY 2 YEARS OR WHEN THEY FAIL A BATTERY TEST. THE AGED BATTERIES EXHIBITED SIGNIFICANTLY REDUCED CAPACITY, CAUSING EARLY LOW-BATTERY WARNINGS AND LOSS OF SUCTION DURING USE. THERE IS NO INDICATION OF DEVICE OR CHARGER MALFUNCTION; THE ISSUE IS ATTRIBUTED TO OVER-AGED BATTERIES THAT WERE NOT REPLACED AS RECOMMENDED. IT IS UNCLEAR WHETHER REGULAR BATTERY AND DEVICE TESTS WERE PERFORMED, AS ADVISED IN THE USER GUIDE. THE BEHAVIOR DESCRIBED BY THE CUSTOMER, SHORT RUNTIME, RAPID LOW-BATTERY INDICATION, AND DECLINING SUCTION, ARE CONSISTENT WITH AN AGED OR END-OF-LIFE NIMH BATTERY BEHAVIOR.

Description of Event or Problem

MEDICAL STAFF AT A HOSPITAL IN FRANCE ATTEMPTED TO USE TWO LCSU4 SUCTION UNITS DURING PATIENT TREATMENT. THE FIRST DEVICE (SERIAL NUMBER (B)(6)) WAS REMOVED FROM ITS CHARGING STATION AND TAKEN TO THE PATIENT'S ROOM. SUCTION WAS INITIATED AT LOW SUCTION. AFTER APPROXIMATELY TWO MINUTES, THE BATTERY LED ILLUMINATED, AND SUCTION DECREASED. THE DEVICE WAS THEN CONNECTED TO A POWER SUPPLY. A SECOND LCSU4 DEVICE (SERIAL NUMBER (B)(6)) WAS SUBSEQUENTLY REMOVED FROM ITS POWER SUPPLY AND BROUGHT TO THE PATIENT. SUCTION WAS INITIATED AT HIGH SUCTION. AFTER APPROXIMATELY FIVE MINUTES, THE BATTERY LED ILLUMINATED, AND SUCTION DECREASED. DURING THE TREATMENT, THE TWO DEVICES WERE ALTERNATED EVERY FEW MINUTES TO MAINTAIN SUCTION. THE TOTAL DURATION OF PATIENT TREATMENT WAS APPROXIMATELY 45 MINUTES. THE PATIENT DIED DURING THE INCIDENT. NO ADDITIONAL INFORMATION REGARDING THE PATIENT'S CONDITION WAS RECEIVED BY LAERDAL.