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

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 02/23/2022

Event Type  malfunction  

Event Description

Reporter calling to report a problem with the replacement cpap machine she received as a result of the philips recall.Caller filed with philips on (b)(6) 2021 to have her recalled device replaced, and it took until (b)(6) 2022 for her to receive her replacement device.The replacement machine does not work despite following all instructions for use, and she has never used the device because it will not reach the appropriate pressure needed to treat her sleep apnea; she requires a machine to operate at pressure of "14" and this machine will only reach "5 or 6." she has been communicating with philips regarding this issue, however a call to them yesterday ((b)(6) 2022) "really pissed me off." she claims philips stated that her cpap machine supplier submitted the order incorrectly and is now essentially refusing to help her.She states that her insurance company, cpap supplier, and philips all point the blame at each other while she is left caught in the middle of all of it.Since the replacement machine will not work, she has been using her original and old resmed machine ever since (b)(6) 2022.She is filing a report because she wants philips held accountable.

• Brand Name: DREAMSTATION CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS/RESPIRONICS, INC.
• MDR Report Key: 14312004
• MDR Text Key: 291249103
• Report Number: MW5109578
• Device Sequence Number: 1
• Product Code: BZD
• 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: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Treatment: RESMED CPAP MACHINE
• Patient Age: 56 YR
• Patient Sex: Female