MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE DISPOSABLE HANDHELD NEBULIZER KITS; DISPOSABLE SMALL VOLUME NEBULIZER / HUMIDIFIER NEBULIZER KIT

Model Number	HCSU4483
Health Effect - Clinical Code	Respiratory Distress (2045)
Date of Event	08/25/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Equipment defect, small volume nebulizer power source tubing leak, delayed treatment of respiratory distress, inhalation aerosol therapy.Recurrent issues.

• Brand Name: MEDLINE DISPOSABLE HANDHELD NEBULIZER KITS
• Common Device Name: DISPOSABLE SMALL VOLUME NEBULIZER / HUMIDIFIER NEBULIZER KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC. ; northfield IL 60093
• MDR Report Key: 7826532
• Report Number: MW5079465
• Device Sequence Number: 2468913
• Product Code: OGG
• UDI-Device Identifier: 10888277657625
• UDI-Public: (01)10888277657625
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: HCSU4483
• Device Catalogue Number: GTIN(01)10888277657625
• Device Lot Number: (10)08518010467
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR