MalfunctionEGJ

GIBSON COOKE

Received Mar 27, 2003

Report 450137 · MDR key 450137

Device

Generic name

Sweat Test Apparatus

Manufacturer

Rodeo Products

Model number

1PS.25A

Catalog number

Lot number

Product problems

Shock, electrical
Grounding Malfunction
Defective Component

Patient

5 YR

Sweating
Electric Shock

Narrative

Description of Event or Problem

DURING SWEAT CHLORIDE COLLECTION, SWEAT COLLECTION DEVICE MALFUNCTIONED ADMINISTERING AN ELECTRICAL SHOCK TO PT. INVESTIGATION REVEALED A DEFECTIVE TRANSISTOR CAUSED THE SHOCK.