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

Device Problems Use of Device Problem (1670); Inadequate Instructions for Non-Healthcare Professional (2956)

Patient Problem Insufficient Information (4580)

Event Date 06/12/2021

Event Type  Injury  

Event Description

I was not notified by manufacturer that cpap machine had a problem and that i should not use it.I did receive contact to order new supplies as recently as today.Fda safety report id# (b)(4).

• Brand Name: CPAP DREAMSTATION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS/ RESPIRONICS, INC.
• MDR Report Key: 12276164
• MDR Text Key: 265261509
• Report Number: MW5102989
• 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: 08/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• 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): Life Threatening
• Patient Age: 70 YR
• Patient Weight: 74