inforMED
MalfunctionFLF

ETHYLENE-OXIDE STERILYZER

Received Jul 25, 1996

Report MW1009570 · MDR key 34638

Device

Generic name

Ethylene-oxide Sterilyzer

Manufacturer

Mdt Biologic Co.

Catalog number

3671 5416565

Product problems

  • Leak/Splash
  • Product Quality Problem

Patient

NA

  • Other (for use when an appropriate patient code cannot be identified)

Narrative

Description of Event or Problem

LEAK IN GASKET OF HEAT EXCHANGERS OF ETO STERILIZER. NEEDED TO BE REPLACED SEVERAL TIMES - POSSIBLE EMPLOYEE EXPOSURE.