inforMED
MalfunctionKTB

*

Received Apr 22, 2010 · Event occurred Apr 20, 2010

Report 1671364 · MDR key 1671364

Device

Generic name

Sweat Test Apparatus

Model number

IPS-25A

Catalog number

*

Lot number

*

Product problems

  • Output above Specifications
  • Charging Problem

Patient

18 MO

  • Partial thickness (Second Degree) Burn

Narrative

Description of Event or Problem

PT'S FOREARM SUSTAINED 3-4 BURN BLISTERS AFTER UNDERGOING SWEAT CHLORIDE TEST. THIS WAS REPORTED BY CHILD'S MOTHER AFTER THEY RETURNED HOME. NO MEDICAL TREATMENT REQUIRED.====================== HEALTH PROFESSIONAL'S IMPRESSION======================LOW VOLTAGE ON SWEAT TEST APPARATUS LEAD TO HIGH AMPS. THIS WAS DUE TO LOW BATTERY CHARGE. BATTERIES REPLACED. RECOMMENDATION BY HOSPITAL BIOMED IS TO CHANGE BATTERIES EVERY 6 MONTHS.====================== MANUFACTURER RESPONSE FOR SWEAT TEST APPARATUS, (BRAND NOT PROVIDED)======================PEDS PULMONARY CLINIC SPOKE WITH MANUFACTURER. I AM UNAWARE WHAT WAS SAID DURING THE CONVERSATION.