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

Model Number EEX3100S19

Device Problem Intermittent Loss of Power (4016)

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

Event Date 03/26/2024

Event Type  malfunction  

Manufacturer Narrative

H3 other text : device not returned to the manufacturer.

Event Description

The manufacturer received information alleging that the device alarms and turns itself off.The device has not been returned to the manufacturer.At this time, we are unable to confirm the alleged malfunction.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: melissa rosko ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 19125304
• MDR Text Key: 340394540
• Report Number: 2518422-2024-20265
• 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: 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 Model Number: EEX3100S19
• Device Catalogue Number: EEX3100S19
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/17/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/27/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1