FDA Adverse Event Malfunction Summary report: N

HEARTSTART XL M4735A

MDR report key: 814286 · Received January 29, 2007

Report

Report Number
814286
Event Type
Malfunction
Date Received
January 29, 2007
Date of Event
January 15, 2007
Report Date
January 29, 2007
Manufacturer
PHILIPS MEDICAL SYSTEMS, INC.
Product Code
MKJ
Product Problem
Yes
Report Source
User Facility report
Reporter Location
IA, US

Narratives

Description of Event or Problem · 1

INFANT BORN WITH SIGNIFICANT MEDICAL PROBLEMS INCLUDING DIGEORGE SYNDROME, TRUNCUS ARTERIOSUS, TYPE III; LEFT CLUB FOOT, UMBILICAL HERNIA AND VELO-CARDIO-FACIAL SYNDROME. PATIENT UNDERWENT MAJOR CARDIAC OPERATIONS ON TWO OCCASIONS FOR REPAIR OF COMPONENTS OF HER CONGENITAL HEART DEFECTS. EARLIER THIS YEAR THE PATIENT SUFFERED A CARDIAC ARREST WHILE IN THE PICU. PATIENT'S RHYTHM DETERIORATED INTO V-FIB AFTER SEVERAL MINUTES OF CPR AND DEFIBRILLATION WAS REQUIRED. PHYSICIAN USED PEDIATRIC PADDLES ON PATIENT WITH GOOD CONTACT. PHYSICIAN HIT CHARGE AND THE PADDLES APPEARED TO CHARGE BUT WHEN THE BUTTONS WERE PRESSED TO DISCHARGE THE SHOCK, THE DEFIBRILLATOR WOULD NOT FIRE. ATTEMPTED TO CHARGE AND FIRE MULTIPLE TIMES, BUT WITHOUT SUCCESS. ANOTHER DEFIBRILLATOR BROUGHT TO BEDSIDE, THE PEDIATRIC PATCHES WERE APPLIED TO THE PATIENT'S CHEST AND DEFIBRILLATOR WORKED SUCCESSFULLY. DEFIBRILLATOR EVALUATED IN BIOENGINEERING AND FOUND TO BE FUNCTIONING PROPERLY. RE-ENACTMENT SUGGESTED THAT THE PHYSICIAN WAS CHARGING FROM THE PADDLES AT THE SAME TIME THE NURSE WAS CHARGING FROM THE CONSOLE. DUE TO THE DESIGN OF THE CHARGE/DISARM BUTTON THE NURSE UNKNOWINGLY WAS DISARMING THE CHARGE, RATHER THAN CHARGING. WHEN PADS USED AND CHARGING WAS DONE FROM CONSOLE, THE DEFIBRILLATOR FUNCTIONED APPROPRIATELY. THE NUMBER 2 BUTTON APPARENTLY FUNCTIONS AS A CHARGE/DISCHARGE BUTTON. THE LED DISPLAY THAT INDICATES WHICH FUNCTION IS IN EFFECT IS DIFFICULT TO INTERPRET AND THERE IS CONCERN THAT ONE BUTTON SHOULD NOT HAVE BOTH FUNCTIONS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 HEARTSTART XL M4735A DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS, INC. * *

Patients

Seq Age Sex Outcome Treatment
1 2 MO