AIRLIFE PEDIATRIC BROSELOW TAPES
Received Mar 12, 2026
Report MW5185100 · MDR key 24580628
Device
Generic name
Emergency Response Safety Kit
Manufacturer
Sunmed Group Holdings, Llc Dba AirlifePatient
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).