FDA Adverse Event Injury Summary report: N

AUTOVENT 300

MDR report key: 4898883 · Received July 1, 2015

Report

Report Number
MW5043684
Event Type
Injury
Date Received
July 1, 2015
Date of Event
June 30, 2015
Report Date
July 1, 2015
Manufacturer
LIFE SUPPORT PRODUCTS, INC./ ALLIED HEALTHCARE PRODUCTS
Product Code
CBK
Report Source
Voluntary report
Reporter Location
AR, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

INCORRECT VENTILATOR SETTINGS RESULTED IN AN INTUBATED PATIENT BEING INADEQUATELY OXYGENATED. ERROR IDENTIFIED AS THE PATIENT'S OXYGEN SATURATION DROPPED, AND THE PATIENT WAS REMOVED FROM THE VENTILATOR RETURNED TO 100% SPO2 WITH A BAG. LOWEST SPO2 EXPERIENCED WAS 75%, AND NO PERMANENT DISABILITY EXPECTED. OPERATOR HAD SET VENTILATOR USING "CHILD" SCALE, YET IT WAS IN "ADULT" MODE WITH CONFUSING AND COUNTERINTUITIVE PRODUCT LABELING CONTRIBUTING TO THE ERROR. PRODUCT IS A MECHANICAL DEVICE WITH 3 KNOBS THAT DETERMINE ITS SETTINGS, THE 2 OUTER KNOBS SET TIDAL VOLUME AND VENTILATORY RATE, AND THE MIDDLE KNOB SETS INSPIRATORY TIME, AND THE MODE OF THE VENTILATOR (CHILD OR ADULT). THE SETTING OF THE MIDDLE KNOB IS CRITICAL BECAUSE IT CHANGES THE OTHER 2 SETTINGS. THIS IS NOT ENTIRELY INTUITIVE, AS MOST FOLKS THINK FROM LEFT TO RIGHT. MORE IMPORTANTLY, THE OTHER TWO KNOBS ARE LABELED WITH 2 DIFFERENT SCALES TO CORRELATE WITH THE TWO DIFFERENT MODES, ADULT AND CHILD. CHILD SCALE IS ORANGE, AND ADULT SCALE IS WHITE. HOWEVER, THE CHILD (ORANGE) SCALE IS MUCH LARGER AND CIRCLED, DRAWING THE USER'S EYE, WHILE THE ADULT SCALE IS MUCH SMALLER AND EASY TO MISS. ALSO, THE ADULT SCALE IS ON THE RIGHT (INSIDE), AND THE CHILD SCALE IS ON THE LEFT (OUTSIDE), WHICH IS OPPOSITE FROM THE MODE SETTING WHERE ADULT IS LEFT AND CHILD IS RIGHT. AND THIS IS A TRANSPORT VENTILATOR, DESIGNED TO BE USED MY MINIMALLY TRAINED PERSONNEL IN HIGH-STRESS, LOW-LIGHT SITUATIONS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
426600 AUTOVENT 300 AUTOVENT 300 CBK LIFE SUPPORT PRODUCTS, INC./ ALLIED HEALTHCARE PRODUCTS AUTOVENT 3000 V. 2.0

Patients

Seq Age Sex Outcome Treatment
1 16 YR Life Threatening| R