FDA Adverse Event Malfunction Summary report: N

MICROAIR NE-U22V - EXAMPLE 1 OF 4 BRANDS-

MDR report key: 1917288 · Received December 2, 2010

Report

Report Number
MW5018437
Event Type
Malfunction
Date Received
December 2, 2010
Date of Event
December 2, 2010
Report Date
December 2, 2010
Manufacturer
UNK
Product Code
CAF
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
FL, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I AM A COPD PT 4 YRS. I WOULD LIKE TO PURCHASE A RE-CHARGEABLE HAND HELD PORTABLE NEBULIZER. THE PROBLEM IS, ALL MANUFACTURES ARE USING THE SAME TECHNOLOGY PIZO ELECTRIC VIBRATING SCREEN AND LITHIUM ION BATTERIES, OR 2 AA NON RECHARGEABLE BATTERIES ADVERTISED AS 4 HOURS SERVICE, THE NEXT MFG, 8 HRS IF USED 30 MIN A DAY, THE NEXT 16 DAYS IF USED 15 MINUTES A DAY ALL USING THE SAME BATTERIES. ONLY ONE LISTS FIRE HAZARDS IF OXYGEN IS BEING ADMINISTERED, EXPLOSIVE HAZARD IF CONTACTED WITH WATER, POISON HAZARD IF LEAKING, DO NOT DROP, TEMPERATURE WILL INCREASE 18 DEGREES ABOVE AMBIENT I LIVE IN (B)(6), HURRICANE COUNTRY, AND WOULD DEPEND ON THIS DEVICE TO SAVE MY LIFE WHEN THERE IS A PROLONGED POWER OUTAGE AND IF THE PRODUCT DON'T LIVE UP TO THE 8 HRS, 8 DAYS, OR 16 DAYS AS IS PROMOTED BY INVACARE, THIS COULD COST ME MY LIFE. MY QUESTION IS, WHICH IF ANY OF THESE CLAIMS IS CORRECT BEFORE I PURCHASE ONE. I AM C.O.P.D. PT AND MUST USE A NEBULIZER 6 TO 8 TIMES A DAY TO BREATH. I AM CONSIDERING BUYING A BATTERY POWERED NEBULIZER TO GIVE ME SOME MOBILITY AND TO USE AS AN EMERGENCY BACKUP WHEN ELECTRIC POWER IS INTERRUPTED. THE UNITS ALL USING THE SAME TECHNOLOGY IE: PIZO ELECTRIC VIBRATING SCREEN, AND LITHIUM ION BATTERIES. LIST THEIR PRODUCT AS BEING ABLE TO USE ON ONE CHARGE 2 HRS, OR 4 HRS IF USED AT 30 MIN. OR 8 DAYS IF USED 30 MIN A DAY, OR 16 DAYS IF USED 15 MIN A DAY. ONLY ONE MANUFACTURE LIST 2 HRS ON A 4 HR CHARGE AND THEN LISTS THE HAZARDS OF THIS MACHINE, DO NOT USE IN A OXYGEN RICH ENVIRONMENT, - I USE OXYGEN - EXPLOSIVE DANGER IF CONTACT WITH WATER, DO NOT USE IN A WET ENVIRONMENT, DO NOT DROP, DO NOT CARRY ON AIRLINE. I WOULD SUGGEST THAT (B)(4), EACH ADVERTISING IS AHEAD OF THE TRUTH AND COULD CAUSE SOME ONE THEIR LIFE. THESE CLAIMS NEED TO BE LOOKED INTO. THE TIME ADVERTISED IS FALSE AS THE 30 USE 15 MINUTES IS IN VERY SMALL PRINT TO DECEIVE THE USER.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 MICROAIR NE-U22V - EXAMPLE 1 OF 4 BRANDS- BATTERY POWERED HAND HELD NEBULIZER CAF UNK UNK

Patients

Seq Age Sex Outcome Treatment
1 69 YR Other