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

Model Number 200605C

Device Problem Degraded (1153)

Patient Problems Asthma (1726); Pulmonary Dysfunction (2019); Respiratory Tract Infection (2420); 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 relation to cellular modem alleging nose irritation, respiratory tract irritation, asthma (new or worsening), lung disease.Medical intervention was not specified.No patient information was provided.No additional information can be requested at this time.The manufacturer was made aware of this complaint through a representative of the customer.

Manufacturer Narrative

The manufacturer previously reported information in relation to cellular modem alleging nose irritation, respiratory tract irritation, asthma (new or worsening), lung disease.Medical intervention was not specified.No patient information was provided.No additional information can be requested at this time.The manufacturer was made aware of this complaint through a representative of the customer.On the previously submitted report, the country of occurrence was omitted.It is corrected on this report.

• 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: 19056640
• MDR Text Key: 339547760
• Report Number: 2518422-2024-17808
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959049000
• UDI-Public: 00606959049000
• 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,Followup

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: 200605C
• Device Catalogue Number: 200605C
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/16/2024
• Initial Date FDA Received: 04/06/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/24/2017
• 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