* IPS-25A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-04-22 for * IPS-25A manufactured by C&s Electronics Inc.

Event Text Entries

[21781121] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1671364
• MDR Report Key: 1671364
• Date Received: 2010-04-22
• Date of Report: 2010-04-22
• Date of Event: 2010-04-20
• Report Date: 2010-04-22
• Date Reported to FDA: 2010-04-22
• Date Added to Maude: 2010-05-03
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: *
• Generic Name: SWEAT TEST APPARATUS
• Product Code: KTB
• Date Received: 2010-04-22
• Model Number: IPS-25A
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: C&S ELECTRONICS INC
• Manufacturer Address: 2565 16TH AVENUE COLUMBUS NE 68601 US 68601

Patients

Patient Number	Treatment	Outcome	Date
1	0		2010-04-22