MAUDE Adverse Event Report: SALTER LABS DE MEXICO DE S.A. DE C.V. SALTER AIRE ELITE NEBULIZER & COMPRESSOR; NEBULIZER (DIRECT PATIENT INTERFACE)

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/15/2022

Event Type  malfunction  

Event Description

I purchased a brand new salter aire elite nebulizer from complete care medical supply at (b)(6) on (b)(6) 2021.The nebulizer has a one (1) year warranty.The nebulizer stopped working about (b)(6) 2022.I contacted the owner of complete care medical supply ((b)(6)- no last name available - he would not supply).(b)(6) indicated i had to contact the manufacturer about any warranty service or issues of the nebulizer.So, i contacted salter lab (manufacturer of the nebulizer) at 1-800-421-0024 and provided the serial number of the machine (b)(4).The manufacturer informed me that the normal procedure is to have all warranty issues go through the retail provider.In this case, complete care medical supply in (b)(6).So, i asked salter lab to look up the serial number of my particular unit (b)(4) and they informed me the machine is no longer under warranty? they could not tell me how old the machine was.So, i called the merchant back (complete care medical supply) again to inform him that the manufacturer said the machine is no longer under warranty? they cannot send a replacement for the defective unit (five months old).The merchant "(b)(6)" said that the responsibility to replace the faulty unit belongs to the manufacturer even though he freely admits he sold the unit from his shelf stock.The responsibility should be on the merchant to replace all defective merchandise sold in their retail store."(b)(6)" again indicated it is not his responsibility to replace faulty merchandise and i should be happy i got five (5) months of use out of the nebulizer.All of this went on the middle of (b)(6) and i have been very patient waiting for a resolution.There has been no call backs from "(b)(6)" or any one from complete care medical supply in (b)(6).From the results shown the vendor has no intent on honoring the warranty on the nebulizer he sold to me.I paid a fair price and paid in full via the insurance i have (b)(6).This is fraud.Complete care medical supply's actions show they have no intention to honor the one (1) year warranty and simply want to [invalid]me along hoping that i will drop the issue.They tried to divert their responsibility to honor the warranty by referring me to the manufacturer.The manufacturer can only deal with the retail vendor.So now, i am out of options in getting my broken nebulizer replaced that is under the one (1) year warranty.This will soon negatively affect my lifestyle and health.Please help with the resolution to simply get my broken nebulizer replaced as it is still under the one (1) year warranty.Respectfully, (b)(6).Fda safety report id# (b)(4).

• Brand Name: SALTER AIRE ELITE NEBULIZER & COMPRESSOR
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): SALTER LABS DE MEXICO DE S.A. DE C.V.
• MDR Report Key: 14986849
• MDR Text Key: 295796912
• Report Number: MW5110798
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2022
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: AZITHROMYCIN; MOTRIN; MULTI VITAMIN; OXYGEN COMPRESSOR; TOBRAMYCIN; VIBRATING VEST (LUNG CLEARING); VITAMIN E
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 44 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian