FDA Adverse Event Other Summary report: N

BUNNELL

MDR report key: 168086 · Received May 11, 1998

Report

Report Number
MW1013832
Event Type
Other
Date Received
May 11, 1998
Date of Event
January 16, 1997
Report Date
January 17, 1997
Manufacturer
BUNNELL, INC.
Product Code
LSZ
Report Source
Voluntary report
Reporter Occupation
RESPIRATORY THERAPIST

Narratives

Description of Event or Problem · 1

HIGH FREQUENCY JET VENTILATOR CEASED TO FUNCTION PROPERLY. PT WAS PLACED ON CONVENTIONAL MECHANICAL VENTILATOR WHILE MFR WAS CONTACTED FOR ASSISTANCE. MFR CONFIRMED JET VENTILATOR WAS PROBABLY FAULTY; ARRANGED REPLACEMENT AND ISSUED INSTRUCTIONS & AUTHORIZATION FOR RETURN.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 BUNNELL LIFE PULSE HIGH FREQUENCY JET VENTILATOR LSZ BUNNELL, INC. CD-185-17 *

Patients

Seq Age Sex Outcome Treatment
1 1 DAY Other