MAUDE Adverse Event Report: RESPIRONICS, INC. PHILIPS BIPAP SYSTEM ONE; VENTILATOR, CONTINUOUS, NON-LIFE SUPPORTING

Device Problem Degraded (1153)

Patient Problem Pulmonary Emphysema (1832)

Event Date 12/14/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The manufacturer received a voluntary medwatch (mw5106128) 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, "i have been using these respironic machines for 15 years: 2 system ones and 2 dreamstation, all of these units have been recalled by philips within the last 2 year my wife and i have both been diagnosed with emphysema." medical intervention was not specified.The device has not yet been returned to the manufacturer for evaluation.At this time, we are unable to obtain additional information through good faith effort attempts due to lack of customer contact information and therefore no further investigation can be performed.If any additional information is received at a later date, a follow up report will be filed.

• Brand Name: PHILIPS BIPAP SYSTEM ONE
• 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: 17652302
• MDR Text Key: 322308054
• Report Number: 2518422-2023-21305
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/31/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: RES 88058
• Patient Sequence Number: 1
• Patient Outcome(s): Other