MAUDE Adverse Event Report: SALTER LABS HUMIDIFIER BOTTLE; HUMIDIFIER, RESPIRATORY, GAS, DIRECT PATIENT INTERFACE

Model Number 7600

Device Problem Crack (1135)

Patient Problem Dyspnea (1816)

Event Date 01/25/2020

Event Type  Injury  

Event Description

My oxygen supplier has sent me humidifier bottles, model #7600 from (b)(6) labs to use with my oxygen concentrator.I have had to throw 2 bottles away in less than 2 weeks because they keep cracking on the side.I¿m very careful when i handle these, and i¿ve not dropped either of them.The first incident occurred on (b)(6) 2020.On both occasions it did affect my oxygen intake levels, and it made my breathing problems much worse because i wasn't getting the correct amount of oxygen.I could hardly get up and move around because i couldn't catch my breathe.I already have enough problems breathing, and i can barely make it around the house without having to sit down.I sure don't need defective equipment making it worse.This i did send them an email today regarding this issue.I¿ve looked online and found numerous complaints from consumers having the same problem.They really shouldn't be allowed to sell this product.Fda safety report id # (b)(4).Fda received date: 01/25/2020.

• Brand Name: HUMIDIFIER BOTTLE
• Type of Device: HUMIDIFIER, RESPIRATORY, GAS, DIRECT PATIENT INTERFACE
• Manufacturer (Section D): SALTER LABS
• MDR Report Key: 9641662
• MDR Text Key: 177140380
• Report Number: MW5092581
• Device Sequence Number: 1
• Product Code: BTT
• 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: 01/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 7600
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 54 YR
• Patient Weight: 141