inforMED
InjuryFLE

ALL AMERICAN ELECTRIC PRESSURE STEAM STERILIZER

Received Jul 2, 2004 · Event occurred Jun 24, 2004

Report MW1032509 · MDR key 547698

Device

Generic name

Auto Clave

Model number

25X

Catalog number

*

Lot number

*

Product problems

  • Explode

Patient

NA

Narrative

Description of Event or Problem

RPTR WAS AUTO CLAVING INSTRUMENTS. THE AUTO CLAVE EXPLODED. LID POPPED OFF AND WENT THROUGH THE CEILING. NO ONE WAS IN THE ROOM; NO INJURY OCCURRED. AUTOCLAVE LID IS 13 INCHES IN DIAMETER AND IS MADE OF HEAVY METAL. SIX BOLTS ARE SCREWED ONTO LID TO HOLD IN PLACE. EMPLOYEE OPERATING DEVICE VERY EXPERIENCED WITH IT. RPTR PLANS ON TURNING DEVICE OVER TO THE MFR IF FDA IS NOT INTERESTED IN EXAMINING IT.