FDA Adverse Event Malfunction Summary report: N

PHYSIO-CONTROL LIFEPAK 90

MDR report key: 272517 · Received April 4, 2000

Report

Report Number
272517
Event Type
Malfunction
Date Received
April 4, 2000
Date of Event
February 22, 2000
Report Date
March 28, 2000
Manufacturer
PHYSIO-CONTROL
Product Code
LDD
Product Problem
Yes
Report Source
User Facility report
Reporter Location
PA, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

DEFIBRILLATOR MALFUNCTIONED DURING A CARDIOVERSION PROCEDURE IN EP LAB ON 2/22/00. DEFIBRILLATOR FAILED TO DISCHARGE WHEN THE BUTTON WAS PRESSED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 PHYSIO-CONTROL LIFEPAK 90 DEFIBRILLATOR LDD PHYSIO-CONTROL 805460-01 *

Patients

Seq Age Sex Outcome Treatment
1 75 YR