MAUDE Adverse Event Report: 3B MEDICAL INC 3BR LUNA CPAP MACHINE; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number G3 A20

Patient Problems Hemorrhage/Bleeding (1888); Sneezing (2251); Cough (4457); Unspecified Respiratory Problem (4464)

Event Date 12/06/2023

Event Type  Injury  

Event Description

I was issued a 3br luna cpap machine by (b)(6).I began to sneeze incessantly, watery eyes, coughing up voluminous mucus tinged with blood, and nose running that led to constant blowing that cause scans in my nose and bleeding.Reported the adverse effects to my doctor and (b)(6).(b)(6) recommendation was to return the machine but that they did not sell any machines for replacement.

• Brand Name: 3BR LUNA CPAP MACHINE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): 3B MEDICAL INC
• MDR Report Key: 18640768
• MDR Text Key: 334695856
• Report Number: MW5151029
• 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: Patient
• Type of Report: Initial
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: G3 A20
• Device Catalogue Number: LG3800
• Device Lot Number: LUNA G3 APAP
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: AMBIEN.; AZELTINE.; BLOOD PRESSURE MONITOR.; CALCITROL.; CPAP DEVICE. ; DONEZIPRIL.; FLONASE NASAL SPRAYS.; MIDODRINE.; OXYGEN 0.2 LITERS.; PRAVASTATIN.; PROZAC.; SINGULAIRE.; SPRIOLACTONE.; SYMBICORT INHALER.; SYNTHROID.; VIT D 50,000 UNITS.; XANAX.
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American