inforMED
OtherNKJ

HEARTSTART

Received Apr 21, 2006 · Event occurred Apr 27, 2000

Report 9610483-2006-00083 · MDR key 702731

Device

Generic name

Saed

Model number

HS2000

Catalog number

900000/900050

Lot number

NA

Product problems

  • Loss of Power
  • Replace
  • Defibrillation/Stimulation Problem
  • Alarm system, failure of message-battery status
  • Device Displays Incorrect Message

Patient

74 YR

Narrative

Description of Event or Problem

DURING AN INCIDENT IN 2000 INVOLVING A PATIENT THIS DEFIBRILLATOR ANALYZED, STARTED TO CHARGE AND THEN SHUT DOWN PROMPTING "BATTERY ???" (NOT SURE OF THE EXACT PROMPT). A SECOND BATTERY WAS TRIED AND THE SAME THING HAPPENED 6 TIMES, THE UNIT SHUT DOWN WITH A PROMPT. A COUPLE OF TIMES THEY SAW A "SERVICE MANDATORY" MESSAGE. ALS ARRIVED AND SHOCKED THE PATIENT. THE PATIENT WAS PRONOUCED.