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

Model Number FRX3100S14

Device Problem Degraded (1153)

Patient Problem Nodule (4551)

Event Date 07/04/2023

Event Type  malfunction  

Manufacturer Narrative

H3 other text : device has not yet been returned to the manufacturer for evaluation.

Event Description

The manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received information alleging micro nodules in the lungs.The patient required a ct scan in the year 2021.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The manufacturer previously reported information in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received information alleging micro nodules in the lungs.The patient required a ct scan in the year 2021.Additionally, the client reported that on 01/19/2018, elia medical equipped the client with a philips dreamstation expert dating from 12/18/2017.The device information in sections d1, d2, d4 and h4 has been corrected on this report.On the previously submitted report, section b1 was selected as an adverse event.After further review, this report is now being filed as a product problem.H1 has been corrected to type of reportable event, malfunction on this report.Section h6 health effect- impact code has been corrected.In addition, section h9 has been corrected on this report.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: 17574013
• MDR Text Key: 321514095
• Report Number: 2518422-2023-19772
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00606959055100
• UDI-Public: 00606959055100
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K121623
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: FRX3100S14
• Device Catalogue Number: FRX3100S14
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/04/2023
• Initial Date FDA Received: 08/18/2023
• Supplement Dates Manufacturer Received: 01/29/2024
• Supplement Dates FDA Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/14/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1974-2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other