MAUDE Adverse Event Report: JAKIA PORTABLE KIT BUNDLE WITH TRAVEL BAG+; DISINFECTANT, MEDICAL DEVICES

Device Problems Labelling, Instructions for Use or Training Problem (1318); Device Emits Odor (1425); Fumes or Vapors (2529)

Patient Problem Dyspnea (1816)

Event Date 06/02/2020

Event Type  Injury  

Event Description

My mother is copd terminal lung cancer with need of a full face cpap machine.She purchased this machine that hooks up to the cpap and sterilized her machine.The information was difficult for her to understand that she received inside the box and she had my dad help her review the information.He didn't understand it either which isn't normally the case.They decided to take the case and put it in a separate room and close the door.They put the dogs in a different room of the house and closed the doors and were in the room farthest away and the toxic fumes had my mom unable to breathe.After 3 hours she said which was over the recommended time (and the 2 large room air purifier that filters down to.01 micron ) she could still smell the odor that the machine let off.My father may not have sealed the bag correctly was a stated concern my mom had and was reluctant to return the device in hope that it can solve her problem and it was just a user error.I'm now very concerned with many of the issues you describe i feel like she may be hooking up to what kills her in false hopes for sanitation; [5-7 days delivery] sold by (b)(6).Isolation at risk covid-19 in fear and getting infections in her nose.Looking for a better method for sterilization that isn't a risk of putting on a death mask from toxic lingering fumes.I don't track my moms medication but i know she has an incredible amount of financial burden from it.Fda safety report id# (b)(4).

• Brand Name: JAKIA PORTABLE KIT BUNDLE WITH TRAVEL BAG+
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• MDR Report Key: 10128558
• MDR Text Key: 194528979
• Report Number: MW5094885
• Device Sequence Number: 1
• Product Code: LRJ
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• 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): Life Threatening
• Patient Age: 82 YR
• Patient Weight: 86