MAUDE Adverse Event Report: PHILIPS / RESPIRONICS, INC. PHILLIPS DREAMSTATION 2; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problems Nonstandard Device (1420); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 10/01/2021

Event Type  Injury  

Event Description

Received dreamstation 2 and sent my dreamstation that was recalled back to philips.New cpap does not work.I have called philips and after several weeks have not heard from them.I made a second call today and they could tell me nothing.Fda safety report id # (b)(4).

• Brand Name: PHILLIPS DREAMSTATION 2
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12728002
• MDR Text Key: 279561569
• Report Number: MW5105037
• Device Sequence Number: 2
• 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: 10/27/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 51 YR