FDA Adverse Event Summary report: N

PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES

MDR report key: 2880353 · Received December 19, 2012

Report

Report Number
1531186-2012-01798
Date Received
December 19, 2012
Report Date
December 18, 2012
Manufacturer
MEDEL S.P.A.
Product Code
BTI
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
WI, US
Reporter Occupation
MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Description of Event or Problem · 1

MDR DECISION DATE: (B)(6). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. DEALER STATES AEROSOL COMPRESSOR HAS NO POWER. MDR FILED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES 868.6250 BTI MEDEL S.P.A. IRC1710

Patients

Seq Age Sex Outcome Treatment
1 Other