inforMED
InjuryDTA

EP MED SYSTEM

Received Sep 8, 2003 · Event occurred Aug 19, 2003

Report 482168 · MDR key 482168

Device

Generic name

Pacer Sonic

Manufacturer

Ep Med System

Model number

PS6100F1

Catalog number

*

Lot number

*

Product problems

  • Alarm, failure of warning
  • Battery failure

Patient

79 YR

  • Atrial Fibrillation
  • Heart rate, decreased

Narrative

Description of Event or Problem

IN EP LAB FOR AV NODE ABLATION AND PERMANENT PACEMAKER INSERTION. THE BATTERY IN THE PACING UNIT FAILED. THE PT'S HEARTRATE WAS 30. NO WARNING SIGNS OF "LOW BATTERY" WAS SEEN BY ANY OF THE STAFF. IT TOOK ABOUT 2 MINUTES TO CHANGE BATTERY. NO HARM TO PT.