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

Device Problem Material Fragmentation (1261)

Patient Problems Unspecified Infection (1930); Foreign Body In Patient (2687)

Event Date 08/16/2021

Event Type  Injury  

Event Description

As result of using philips cpap dreamstation, noted black residue to machine inside.Laryngitis, bronchitis, sinus infection, requiring antibiotics, inhaler and steroids.To date (b)(6) 2021 unresolved.Still under md care.

• Brand Name: PHILIPS DREAMSTATION CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12540586
• MDR Text Key: 273882759
• Report Number: MW5104242
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): Y
• 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: 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/01/2022
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: PEPCID
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 58 YR
• Patient Weight: 59