MAUDE Adverse Event Report: RESPIRONICS, INC. PHILIPS CPAP DEVICE; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number 1051158

Device Problem Degraded (1153)

Patient Problems Pulmonary Dysfunction (2019); Skin Inflammation/ Irritation (4545)

Event Date 01/16/2024

Event Type  Injury  

Manufacturer Narrative

H3 other text : device not returned to manufacturer.

Event Description

The manufacturer received information in a relation to a heated humidifier alleging inflammatory response and lung disease.Medical intervention was not specified.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• Brand Name: PHILIPS CPAP DEVICE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• 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: 19056872
• MDR Text Key: 339549049
• Report Number: 2518422-2024-17793
• Device Sequence Number: 1
• Product Code: BZD
• 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
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1051158
• Device Catalogue Number: 1051158
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/16/2024
• Initial Date FDA Received: 04/07/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/29/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening