MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC BIPAP A40 SYSTEM SILVER; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE

Model Number R1111177

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem Unspecified Respiratory Problem (4464)

Event Date 10/27/2021

Event Type  malfunction  

Event Description

The manufacturer received information alleging that the pressure in the device did not rise as usual and alleged having respiratory discomfort and not sleeping well.The manufacturer's sales representative visited the patient and confirmed pressure regulation in the unit and replaced in the unit.The patient reported an improvement of their respiratory discomfort.No harm or serious injury was reported.The device was returned to the manufacturer for evaluation.The failure in the supply of pressure was confirmed and the main pca was replaced.The issues were confirmed to be resolved after replacing the parts mentioned.

• Brand Name: BIPAP A40 SYSTEM SILVER
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 1001 murry ridge lane; ste a; murrysville PA 15668
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 1001 murry ridge lane; ste a; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18765874
• MDR Text Key: 336058444
• Report Number: 2518422-2024-09337
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K121623
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• 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: Lay User/Patient
• Device Model Number: R1111177
• Device Catalogue Number: R1111177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2021
• Initial Date Manufacturer Received: 10/27/2021
• Initial Date FDA Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 50 KG