inforMED
MalfunctionMKJ

MEDI-TRACE CADENCE

Received Apr 29, 2026 · Event occurred Mar 6, 2026

Report 1423537-2026-00130 · MDR key 25036697

Device

Generic name

Automated External Defibrillators (non-wearable)

Model number

22770R

Catalog number

22770R-

Lot number

604367X

Product problems

  • Sparking

Patient

NA · Male

  • Burn(s)

Narrative

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE PADS SPARKED DURING RESUSCITATION AND HAD TO BE REMOVED FROM PATIENT. ADDITIONAL INFORMATION RECEIVED ON 24APR2026 STATED THAT THERE WAS NO DELAY IN CARE OR IMPACT TO PATIENT NOTED. THEY WERE ABLE TO CONTINUE ACLS CODE PROTOCOL WITHOUT INTERRUPTION. PATIENT DID HAVE A SMALL 2-3INCH MARK ON SKIN FOLLOWING EVENT. PATIENT'S SKIN WAS CLEAN, DRY, AND INTACT AND PREPPED PROPERLY PRIOR TO PLACEMENT OF PADS AND PATIENT WAS NOT WEARING JEWELRY AT TIME OF EVENT. UNKNOWN IF OXYGEN WAS BEING USED. PATIENT EXPIRED WHICH WAS UNRELATED TO THE REPORTED PRODUCT OR EVENT.

Additional Manufacturer Narrative

AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.