MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP A40 PRO; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE

Model Number RGBX3100S19

Device Problem Pressure Problem (3012)

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

Event Date 01/03/2024

Event Type  malfunction  

Manufacturer Narrative

H3 other text : device not returned to manufacturer.

Event Description

The manufacturer received information alleging an issue with the device pressures.There was no harm or injury reported.Patient received a new a40 pro via the uno remediation program on 30th october.Patient contacted her hospital, (b)(6), to advise that she didn't think the pressures felt right.Sd card was retrieved, reviewed and confirmed that the device was on the wrong settings, having not been set prior to dispatch from third-party service center.As a result, patient has been receiving sub-optimal therapy.Hospital has not indicated that this has had an adverse effect on patient's health.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• Brand Name: BIPAP A40 PRO
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18798638
• MDR Text Key: 336456266
• Report Number: 2518422-2024-10358
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K121623
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial

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
• Device Operator: Lay User/Patient
• Device Model Number: RGBX3100S19
• Device Catalogue Number: RGBX3100S19
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/03/2024
• Initial Date FDA Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/06/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1