MAUDE Adverse Event Report: SUNSET HEALTHCARE SOLUTIONS, INC. CANNULA, WITH 4FT SUPPLY TUBE; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number RES1104S

Device Problems Device Emits Odor (1425); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 01/20/2023

Event Description

Received oxygen cannulas from oxygen supplier that are unusable due to debilitating chemical smell.The smell resembles airplane glue and is overpowering.Unsafe due to offgassing of solvents.

• Brand Name: CANNULA, WITH 4FT SUPPLY TUBE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): SUNSET HEALTHCARE SOLUTIONS, INC.
• MDR Report Key: 16242315
• MDR Text Key: 308170751
• Report Number: MW5114493
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 01/20/2023

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?: No
• Device Operator: Other
• Device Model Number: RES1104S
• Device Catalogue Number: RES1104S
• Device Lot Number: 22009402
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/24/2023
• Patient Sequence Number: 1
• Treatment: ANORO ELLIPTA; ARALAST IV; BENADRYL; CYMBALTA; METOPROLOL; NORCO 10/325; PRILOSEC; PROAIR INHALER; SUPPLEMENTAL OXYGEN; ZETIA
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian