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

Model Number DREAMSTATION

Device Problems Entrapment of Device (1212); Nonstandard Device (1420); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/01/2020

Event Type  Injury  

Event Description

While sleeping with my philips cpap machine, something broke off and i unknowingly inhaled it.The artifact became lodged in my right lung.When i reported this to (b)(6), i was told they'd replace the machine.A second machine later had a similar problem.I reported this to my doctors (before we knew about the recall), and they dismissed me.Fda safety report id# (b)(4).

• Brand Name: CPAP DREAMSTATION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12804113
• MDR Text Key: 280819527
• Report Number: MW5105271
• Device Sequence Number: 2
• Product Code: BZD
• Combination Product (y/n): N
• 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: 11/08/2021
• 2 Devices were Involved in the Event: 1 2

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: DREAMSTATION
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/10/2021
• Patient Sequence Number: 1
• Treatment: ANTI-SPASMODICS/ASTHMA TREATMENTS; CPAP; MOBILITY DEVICES; MULTI-VITAMIN; VIT D; VIT K2
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White