inforMED
MalfunctionOKI

AIRLIFE PEDIATRIC BROSELOW TAPES

Received Mar 12, 2026

Report MW5185100 · MDR key 24580628

Device

Generic name

Emergency Response Safety Kit

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

WE HAVE IDENTIFIED ANOTHER ERROR ON THE PEDIATRIC BROSELOW TAPES MANUFACTURED BY AIRLIFE. THIS IS IN RELATION TO SPECIFICALLY IN THE ¿PAIN DOSE¿ SECTION FOR KETAMINE. THE INTENDED DOSE OF 0.1 MG/KG IS INCORRECTLY LISTED AS 1 MG/KG, WHICH REFLECTS INDUCTION/SEDATION DOSING RATHER THAN PAIN DOSING. THIS ERROR APPEARS IN BOTH THE CALCULATION SECTION AND THE COLORED DOSING SECTIONS, RESULTING IN POTENTIAL SIGNIFICANT HARM IF THE RECOMMENDED DOSE (A 10-FOLD INCREASE IN DOSE) IS UTILIZED. THIS IS IN ADDITION TO THE PREVIOUSLY IDENTIFIED FLUMAZENIL AND VECURONIUM DOSING ERRORS. WE HAVE BEEN NOTIFIED THAT THE MANUFACTURER IS NOT EXPECTED TO REPLACE THE TAPES UNTIL Q2 OF 2026 AT THE EARLIEST. (B)(4). (B)(6).