inforMED
MalfunctionDRO

MEDI-TRACE CADENCE

Received Nov 5, 2024 · Event occurred Aug 5, 2024

Report 20609346 · MDR key 20609346

Device

Generic name

Pacemaker, Cardiac, External Transcutaneous (non-invasive)

Model number

22770R

Catalog number

22770R

Patient

65 YR · Male

  • Burn(s)
  • Burn(s)

Narrative

Description of Event or Problem

ADULT MALE PATIENT SCHEDULED FOR CARDIOVERSION UNDER ANESTHESIA CARE. DEFIBRILLATOR PADS APPLIED AND MONITOR TURNED ON TO SYNCH MODE AT 200J PER PROTOCOL. PATIENT INDUCED AND ONCE IN DEEP SEDATION CARDIOLOGIST CONFIRMED SETTINGS ON ZOLL, CHARGED ZOLL AND CLEARED ALL TO SHOCK. THE PATIENT RESPONDED SUCCESSFULLY AND WAS CARDIOVERTED FROM ATRIAL FIBRILLATION (AFIB) TO SINUS RHYTHM (SR). CARDIOLOGIST SMELLED A SLIGHT BURNING SMELL AND ASKED REGISTERED NURSE (RN) IF SHE SMELLED BURNING, AS WELL. RN REMOVED HER MASK AND CONFIRMED. RN ASSESSED THE ZOLL FIRST, NOTHING WAS MALFUNCTIONAL, NO SMELL; THEREFORE, RN FOLLOWED THE CORDS. SHE PROCEEDED TO ASSESS FIRST PAD WHICH WAS MID-ANTERIOR, REMOVED, AND FOUND THAT SKIN WAS INTACT. THE SECOND PAD ASSESSED WAS THE LEFT LATERAL CHEST WALL, PAD REMOVED, AND BURN MARK NOTED. BURN MARK WAS ABOUT A 1 TO 1 1/2 INCH IN LENGTH WELL-APPROXIMATED, NOTED TO BE RED IN COLOR WITH PINK EDGES, AND APPEARING LIKE THE EDGE OF THE DEFIB PAD, NO OOZING FROM SITE. THERE WAS NO BLEEDING, AND THE SITE WAS ASSESSED WITH RN & CARDIOLOGIST. PATIENT WOKE UP FROM ANESTHESIA AND DENIED PAIN. SUCCESSFULLY TRANSFERRED TO INPATIENT REHABILITATION UNIT (IRU) FOR RECOVERY. RN INPUT: RN STATED THERE WAS NOTHING WRONG WITH THE PADS AND THEY WERE INTACT WHEN APPLIED. AFTER THE SHOCK WAS DELIVERED, THE DOCTOR NOTICED A BURNING SMELL, AND WHEN RN TRACED THE CORD DOWN TO THE PAD, SHE NOTICED THE PIECE THAT WAS NOT INTACT AFTER THE SHOCK HAD BEEN DELIVERED. THE BURN MARK MATCHED THE TEAR IN THE PAD. ZOLL WAS EVALUATED BY CLINICAL ENGINEERING AND PASSED ALL TESTING.