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

Device Problem Nonstandard Device (1420)

Patient Problems Dyspnea (1816); Irritability (2421); Swollen Lymph Nodes/Glands (4432)

Event Date 04/02/2010

Event Type  Injury  

Event Description

Patient called to report side effects she believes could be related to her two recalled philips cpap machines.Patient stated that she got her first cpap machine on (b)(6) 2010, and her second cpap machine on (b)(6) 2019 and that both of the devices had been recalled.Patient stated over the years, she's experienced throat irritation, shortness of breath, and swollen glands.Patient stated she believes these symptoms could be related to the recalled cpap devices.

• Brand Name: PHILIPS CPAP MACHINE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS INC.
• MDR Report Key: 12370278
• MDR Text Key: 268471746
• Report Number: MW5103506
• Device Sequence Number: 2
• Product Code: BZD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/25/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 80 YR