inforMED
MalfunctionHMF

AC POWERED INSTRUMENT STAND - 777 WALL TRANSFORMER SET(INCLUDING OTOSCOPES, OPH

Received Feb 21, 2017 · Event occurred Feb 16, 2017

Report 6345025 · MDR key 6345025

Device

Generic name

Stand, Instrument, Ac-powered, Ophthalmic

Manufacturer

Welch Allyn, Inc.

Model number

777

Catalog number

408282

Lot number

15231

Product problems

  • Break
  • Fluid/Blood Leak
  • Sparking
  • Flare or Flash

Patient

14 YR

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

WHILE PATIENT WAS RECEIVING O2 FLOW THERAPY IN THE PICU, THE OTO-OPHTHALMOSCOPE DIAGNOSTIC SET'S PLUG IN AC POWER CONNECTOR SHORTED AND CAUSED AN ELECTRICAL FLASH AND SPARKS RESULTING IN DAMAGE TO THE CONNECTOR AND SURROUNDING AC OUTLET. THE PATIENT WAS DISCONNECTED FROM MONITORING AND O2 THERAPY AND EVACUATED FROM THE ROOM. THE CLINICIAN REMOVED THE POWER CONNECTOR FROM THE AC OUTLET AND NOTIFIED MANAGEMENT AND ENGINEERING. INVESTIGATION DETERMINED THAT FLUID FROM THE DISPOSABLE NEBULIZER HAD LEAKED ONTO THE AC POWER CONNECTOR AND CAUSED THE SHORT. BIOMEDICAL NOTED A POSSIBLE DESIGN FLAW IN THE CONNECTOR THAT WOULD ALLOW FLUID INTRUSION. BIOMEDICAL REMOVED THE DEVICE FROM PICU FOR REPORTING TO FDA MEDWATCH MAUDE DATABASE AND NOTIFICATION OF THE DEVICE MANUFACTURER. NO PATIENT HARM RESULTED FROM THIS EVENT.