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

Device Problem Product Quality Problem (1506)

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

Event Type  malfunction  

Event Description

Received a "recertified device" from philips due to recall, i'm not happy using someone's machine nor will i notify philips.Lady rude by way told her i wasn't satisfied with this machine, she said she could make a complaint for me but that's all.She would do, gave me a reference #(b)(4) from reading.I'm not the only one not satisfied with receiving a used machine.Fda safety report id# (b)(4).

• Brand Name: PHILIPS DREAMSTATION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS/RESPIRONICS, INC.
• MDR Report Key: 15537186
• MDR Text Key: 301192977
• Report Number: MW5112402
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Sex: Female