FDA Adverse Event Injury Summary report: N

QUIK COMBO

MDR report key: 1747981 · Received June 22, 2010

Report

Report Number
1747981
Event Type
Injury
Date Received
June 22, 2010
Date of Event
June 9, 2010
Report Date
June 17, 2010
Manufacturer
PHYSIO-CONTROL INC.
Product Code
MKJ
Adverse Event
Yes
Product Problem
Yes
Report Source
User Facility report
Reporter Location
WV, US

Narratives

Description of Event or Problem · 1

PATIENT WAS IN SURGERY, NEAR END OF A REPEAT CABG OPERATION WITH DEFIBRILLATOR ELECTRODE PADS PLACED ON THE LEFT AND RIGHT SIDES. PATIENT BEGAN VENTRICULAR FIBRILLATION, AND DEFIBRILLATION WAS ATTEMPTED VIA THE EXTERNAL PADS 5-6 TIMES AT 200 JOULE SETTING. THEN SEVERAL ATTEMPTS WERE MADE USING INTERNAL DEFIB PADDLES, WHICH SUCCEEDED. WHILE ATTEMPTING TO CLOSE THE PATIENT'S CHEST, V-FIB OCCURRED AGAIN AND SEVERAL MORE DEFIB ATTEMPTS WERE MADE USING THE EXTERNAL PADS AND A 360 JOULE SETTING, UNTIL THE DEFIBRILLATOR ALARMED THAT THE PADS WERE NOT SECURELY CONNECTED. INSPECTION REVEALED THAT THE LEADWIRE HAD SEPARATED FROM THE LEFT-SIDE PAD. UNDER THE WIRE WAS A BLISTER 5 CM LONG ON THE PATIENT'S LEFT FLANK NEAR THE ARM PIT, WITH A CHARRED REGION AROUND THE BLISTER. THE ELECTRODE PADS WERE REPLACED WITH A NEW SET. AFTER A FEW MORE DEFIBRILLATION ATTEMPTS, THE PATIENT RECOVERED, THEN WAS SENT FROM THE OR TO THE CRITICAL CARE UNIT WHERE THE BLISTERED AREA WAS TREATED WITH AN APPROPRIATE DRESSING. PATIENT WAS EVENTUALLY DISCHARGED TO HOME. THE SKIN INJURY WAS GRANULATING BY THAT TIME AND THE PATIENT'S INSTRUCTIONS WERE TO CONTINUE KEEPING THE AREA COVERED WITH A DRESSING.HEALTH PROFESSIONAL'S IMPRESSION:THE BROKEN OR SEPARATED ELECTRODE WIRE WAS ATTRIBUTED TO MECHANICAL STRESSES FROM THE PATIENT'S SEVERE MUSCLE CONTRACTIONS DURING REPEATED DEFIBRILLATION ATTEMPTS.MANUFACTURER RESPONSE FOR ELECTRODE, DEFIBRILLATOR PADS, QUIK COMBO: MFR STATED THAT QUIK COMBO PADS SHOULD BE REPLACED AFTER 25 DISCHARGES, AND WAS UNAWARE OF PROBLEMS WITH OUR LOT NUMBER.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 QUIK COMBO ELECTRODE, DEFIBRILLATOR, PADS MKJ PHYSIO-CONTROL INC. * 935802

Patients

Seq Age Sex Outcome Treatment
1 45 YR Other| R