FDA Adverse Event Summary report: N

PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES

MDR report key: 3003061 · Received March 13, 2013

Report

Report Number
1531186-2013-01056
Date Received
March 13, 2013
Report Date
February 15, 2013
Manufacturer
MEDEL S.P.A.
Product Code
BTI
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
OH, US
Reporter Occupation
MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Description of Event or Problem · 1

(B)(4) THE DEALER REPORTED THAT THE IRC1710 AEROSOL COMPRESSOR HAD NO OUTPUT PRESSURE. THERE WAS NO PATIENT INJURY REPORTED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
105094 PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES 868.6250 BTI MEDEL S.P.A. IRC1710

Patients

Seq Age Sex Outcome Treatment
1 47 Other