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

Device Problems Output Problem (3005); Unexpected Shutdown (4019)

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

Event Date 12/26/2022

Event Type  malfunction  

Event Description

Respironics dreamstation 2 auto cpap advanced ((refdsx520h11c, sn (b)(4)) seemingly spontaneously ceased to function last night when i was getting ready for bed.I have had the machine, i believe, since approximately (b)(6) 2022 (it was sent as a replacement for the recalled units manufactured by philips corp).The mfg date is 2022-02-08.After repeated attempts to reboot the machine/determine the issue, to no avail, the machine displayed the message "service required." i called the associated customer service number and the person assisting me informed me there would be a 6-8 week delay in sending me a new machine.Not good news as i do not use this machine for the fun of it but because it has been prescribed for me.

• Brand Name: DREAMSTATION 2 AUTO CPAP ADVANCED
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS /RESPIRONICS, INC.
• MDR Report Key: 16077421
• MDR Text Key: 306526453
• Report Number: MW5114085
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 006006959062733
• UDI-Public: (01)006006959062733
• Combination Product (y/n): N
• 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: 12/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: AMLODIPINE BESYLATE; FENOFIBRIC ACID ; MULTI-VITAMIN
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White