MalfunctionDRL

ZAP-GUARD

Received Jan 16, 1998 · Event occurred Jan 16, 1998

Report MW1012826 · MDR key 144899

Device

Generic name

Sterile Defibrillator System Test Probe

Manufacturer

Guardian Angel Products, Inc.

Model number

Catalog number

91766

Lot number

7112M

Product problems

Material Puncture/Hole
Tear, Rip or Hole in Device Packaging

Patient

Narrative

Description of Event or Problem

STERILE DEFIBRILLATOR SYS TEST PROBE PUNCTURES PACKAGING MATERIAL. METAL TIPS OF PROBE PUNCTURE OUTSIDE OF PACKAGING MATERIALS. PACKAGING HAS CHANGED FROM HEAVY PLASTIC AND TYVAK TO PVC AND TYVAK MATERIAL.