FDA Adverse Event Summary report: N

PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES

MDR report key: 3011798 · Received March 19, 2013

Report

Report Number
1531186-2013-01146
Date Received
March 19, 2013
Report Date
February 20, 2013
Manufacturer
MEDEL S.P.A.
Product Code
BTI
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
SD, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

PER CONSUMER, ONCE THE MOUTH PIECE IS HOOKED UP TO THE MACHINE, THERE IS NO AIR COMING THROUGH THE MACHINE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
113580 PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES 868.6250 BTI MEDEL S.P.A. IRC1710

Patients

Seq Age Sex Outcome Treatment
1 Other