MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE NEBULIZER; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number HCS70004

Device Problems Contamination (1120); Detachment of Device or Device Component (2907); Temperature Problem (3022)

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

Event Date 12/29/2022

Event Type  malfunction  

Event Description

Medline nebulizer got hot at use, tubing fell off unit.Inspected tubing and a black foam piece came out of unit into tubing.Same thing happened with my philips unit a couple years ago.

• Brand Name: MEDLINE NEBULIZER
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.
• MDR Report Key: 16094465
• MDR Text Key: 306695296
• Report Number: MW5114137
• 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: 12/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: HCS70004
• Device Catalogue Number: HCS70004
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White