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

Model Number SYSTEM ONE

Device Problems Material Fragmentation (1261); Nonstandard Device (1420)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/14/2021

Event Type  Injury  

Event Description

Appointment with (b)(6) sleep department concerning my cpap machine, the black flecks in my nasal piece, the recall on the product, side effects i've noticed and possibilities of replacing my machine via my insurance.Fda safety report id # (b)(4).

• Brand Name: PHILIPS RESPIRONICS SYSTEM ONE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS INC.
• MDR Report Key: 12532730
• MDR Text Key: 273648299
• Report Number: MW5104215
• Device Sequence Number: 1
• 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: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SYSTEM ONE
• Device Catalogue Number: REF 560P
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 136