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

Model Number DSX500H11

Device Problem Product Quality Problem (1506)

Patient Problems Unspecified Eye / Vision Problem (4471); Liver Failure (4492)

Event Date 11/17/2018

Event Type  Injury  

Event Description

Used philip's dreamweaver cpap/bipap and now am incapacitated with ipf, a liver and an eye problem.Discovered bogus legal websites but would like to join a class action suit.I was in (b)(6) when illness occurred and i now live in (b)(6).Fda safety report id# (b)(4).

• Brand Name: PHILIP'S RESPIRONICS DREAMSTATION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12703883
• MDR Text Key: 278801865
• Report Number: MW5104963
• 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: 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/29/2018
• Device Model Number: DSX500H11
• Device Catalogue Number: (01)00606959022478
• 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): Hospitalization; Other; Disability
• Patient Age: 68 YR