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

Model Number D131650163D635

Device Problems Nonstandard Device (1420); Data Problem (3196)

Patient Problem Insufficient Information (4580)

Event Date 10/01/2021

Event Type  malfunction  

Event Description

My cpap machine philips dreamstation 1 was affected by the recall.I got a dreamstation 2.The dreamstation 2 also allows users to save data on an sd card, but the data is encrypted and the user cannot access it.Philips claims that they don't have a solution for this, yet the solution would be simply: allow users to save their data unencrypted.Fda safety report id# (b)(4).

• Brand Name: DREAMSTATION 2 ADVANCED CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12703832
• MDR Text Key: 278827582
• Report Number: MW5104961
• 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
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: D131650163D635
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 100