FDA Adverse Event Death Summary report: N

DEFIBRILLATOR/PACEMAKER

MDR report key: 1213484 · Received October 29, 2008

Report

Report Number
1213484
Event Type
Death
Date Received
October 29, 2008
Date of Event
October 12, 2008
Report Date
October 20, 2008
Manufacturer
ZOLL MEDICAL CORP
Product Code
LDD
Adverse Event
Yes
Product Problem
Yes
Report Source
User Facility report
Reporter Location
PA, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

ZOLL DEFIB AT 10-15J; PT CTB.SMDA CLINICAL INFORMATION: A PT CAME TO THE ED WITH CHEST PAIN AND ALMOST IMMEDIATELY WENT INTO VFIB. ZOLL PADS WERE ATTACHED TO PT AND DEFIB WAS CHARGED. IT WAS THEN NOTED THAT THE WIRES FROM THE PADS WERE NOT CONNECTED TO THE DEFIBRILLATOR. THE CABLE FROM THE MACHINE WAS CONNECTED TO THE PADDLES INSTEAD. THE STAFF REMOVED THE CONNECTION FROM THE PADDLES AND INSERTED IT INTO THE CONNECTION FROM THE PADS. AT THIS POINT, THE DEFIB WAS CORRECTLY CONNECTED TO THE PADS ON THE PT. THE MACHINE WAS CHARGED AND THE PT WAS DEFIBRILLATED. WHAT WAS NOT KNOWN AT THE TIME WAS THAT DEFIB HAD RESET ITSELF TO 10 JOULES. WE FOUND LATER FROM THE PRINTOUT FROM THE DEFIBRILLATOR THAT THE PT WAS SHOCKED TWICE WITH 10 JOULES. NEITHER SHOCK WAS EFFECTIVE IN GETTING THE PT OUT OF VFIB, THOUGH THE STAFF DID NOTE MOVEMENT OF THE PT INDICATING THAT HE HAD REC'D A SHOCK. AFTER THE CODE, THE ZOLL DEFIBRILLATOR/PACEMAKER WAS REMOVED FROM SERVICE AND TESTED BY INTERNAL BIOMEDICAL PERSONNEL. THE ZOLL TURNED ON AT 120 JOULES AND FUNCTIONED APPROPRIATELY IF THE CABLES WERE CONNECTED TO THE PADS BEFORE CHARGING THE DEFIBRILLATOR. HOWEVER, EACH TIME THE DEFIB WAS TESTED BY CHARGING IT AND THEN DISCONNECTING THE CABLE FROM THE PADDLES IN ORDER TO RE-ATTACH IT TO THE CABLE FROM THE PADS, THE DEFIB CHARGE DROPPED DOWN TO 10 JOULES ON THE SCREEN. THIS MODE OF FUNCTION WAS NOT KNOWN TO THE ED STAFF, THE EDUCATOR, OR THE ZOLL REPRESENTATIVE. THE DEFIB/PACER WAS SENT TO ZOLL WITH THE REP FOR ANALYSIS TO SEE IF THIS FUNCTIONALITY WAS PROGRAMMED INTO THE DEFIBRILLATOR OR IF THIS WAS A MALFUNCTION SPECIFIC TO THIS ONE PIECE OF EQUIPMENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 DEFIBRILLATOR/PACEMAKER CARDIOVASCULAR PRODUCTS LDD ZOLL MEDICAL CORP T01C20594

Patients

Seq Age Sex Outcome Treatment
1 48 YR Death