MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP A40 PRO; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number DEX3100S13

Device Problem Pressure Problem (3012)

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

Event Date 12/12/2023

Event Type  malfunction  

Manufacturer Narrative

The bipap a40 pro, model# dex3100s13 is substantially similar to the bipap a40, model# 1111169 and will be reported in the united states under bipap a40 pro, 501k number: 121623.H3 other text : device not returned to the manufacturer.

Event Description

The manufacturer received information alleging there were multiple pressure controls listed in the alarm log.There was no harm or injury reported.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, NON-LIFE-SUPPORTING
• 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: 18333815
• MDR Text Key: 330555612
• Report Number: 2518422-2023-35763
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00606959055186
• UDI-Public: 00606959055186
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K121623
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• 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: Other
• Device Model Number: DEX3100S13
• Device Catalogue Number: DEX3100S13
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/12/2023
• Initial Date FDA Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/28/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1