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Received Apr 22, 2010 · Event occurred Apr 20, 2010
Report 1671364 · MDR key 1671364
Device
Generic name
Sweat Test Apparatus
Manufacturer
C&s Electronics IncModel number
IPS-25ACatalog number
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Lot number
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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.