CDRH MEDICAL DEVICE REPORTING SYSTEM 13-FEB-96

EVENT REPORT DETAIL LISTING Page: 5
FOI RELEASABLE FORMAT
SORTED BY MEDICAL SPECIALTY & PRODUCT CODE
RECORDS MEETING QUERY CRITERIA

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Internal Report No: 26976 Date Received: 01-AUG-95
Reporting Facility Type: HOSPITAL
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PATIENT INFORMATION

Age: 21 YR. DOB: Sex: M weight: kgs /lbs

ADVERSE EVENT OR PRODUCT PROBLEM

Adverse Event: Y Product problem: Y
Outcomes attributed to event: REQUIRED INTERVENTION

Event Date: O7-JUN-95 Date of Report: 23-JUN-95

Event Description.

PT WAS UNDERGOING ELECTROCONVULSIVE THERAPY. WHEN STIMULUS FOR ECT WAS DELIVERED, A WIRE BROKE. SPARKS IGNITED THE OXYGEN APPARATUS.

DEVICE IDENTIFICATION

Brand:ELECTROCONVULSIVE UNIT
Generic:ELECTROCONVULSIVE UNIT
Project Code: GXC(NE) - DEVICE, ELECTROCONVULSIVE THERAPY

Manufacturer: MECTA, CORP.
Short name:MECTA
Address:7015 SW MCEWAN RD
LAKE OSWEGO, OR 97035

Model: SR-I
Catalog:

Device Operator: HEALTH PROFESSIONAL
Expiration Date:
Device available For Evaluation: Y
Treatment:OXYGEN FACE MASK WITH 5L OXYGEN AND AMBU BAG WITH Date:
Treatment: 5L OXYGEN. Date:


USER FACILITY INFORMATION

Date of Awareness: 07-JUN-95 Type of Report: I Date of Report: 23-JUN-95
Age of Device: 18 MO