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

Model Number EEX3100S19

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 12/22/2023

Event Type  malfunction  

Event Description

The manufacturer received information alleging a ventilator inoperative condition occurred.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.

Manufacturer Narrative

H3 other text : device not returned to manufacturer.

• Brand Name: BIPAP A40 PRO
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): RESPIRONICS, INC.; 6501 living place; pittsburgh PA 15208
• Manufacturer (Section G): RESPIRONICS, INC.; 6501 living place; pittsburgh PA 15208
• Manufacturer Contact: melissa rosko ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 19187793
• MDR Text Key: 341129655
• Report Number: 2518422-2024-22560
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00606959059139
• UDI-Public: 00606959059139
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K121623
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• 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 Model Number: EEX3100S19
• Device Catalogue Number: EEX3100S19
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/22/2023
• Initial Date FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/24/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1