MAUDE Adverse Event Report: GALEMED CORP. BABI.PLUS; ATTACHMENT, BREATHING, POSITIVE END EXPIRATORY PRESSURE

Model Number	BC51-AU
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	08/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Patient setup up on bubble cpap [continuous positive airway pressure].The respiratory therapist was called to bedside to assess patient due to desaturation.While assessing the patient, the respiratory therapist felt flow on her arm coming from a place it should not have.When she inspected the o2 tubing that goes from the pop off valve to the flow meter she noticed a leak and heard the flow.Patient was switched to another device without issue.

• Brand Name: BABI.PLUS
• Common Device Name: ATTACHMENT, BREATHING, POSITIVE END EXPIRATORY PRESSURE
• Manufacturer (Section D): GALEMED CORP.; 2500 bee cave rd.; bldg. 1, ste. 300; austin TX 78746
• MDR Report Key: 23050719
• Report Number: 23050719
• Device Sequence Number: 13203899
• Product Code: BYE
• UDI-Device Identifier: 24710810093559
• UDI-Public: (01)24710810093559
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/12/2025
• Report Date (Section F): 08/14/2025

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: BC51-AU
• Device Catalogue Number: BUBBLE PAP VALVE WITH 12.5 CM
• Device Lot Number: 241203
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 09/15/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/15/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 1 DA
• Patient Sex: Male
• Patient Weight: 3 KG
• Date Report Sent to FDA: 08/14/2025