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

Device Problem Nonstandard Device (1420)

Patient Problems Low Oxygen Saturation (2477); Convulsion/Seizure (4406)

Event Date 03/16/2018

Event Type  Injury  

Event Description

I began using the philips respironics dream station s/t for my daughter in (b)(6) 2017.She had her first seizure in (b)(6) 2018 while sleeping on the continuous ventilatory support machine mentioned above.The seizures have increased in number since then and she has an average of 30 or more seizures per month, sometimes in clusters of up to 12 or 13 seizures in a 24 hour period.This has severely altered her quality of life.She has been put on various anti-seizure medications, yet the seizures have continued.Many of the seizures have been life-threatening as she has stopped breathing during seizures with oxygen saturation levels dropping as low as 12%.We received notification of the urgent, life-threatening, class 1 recall yesterday evening via (b)(6) only to learn this morning that philips respironics knew about this problem much earlier, and began sending letters out on june 12, 2021.When i followed all of the steps philips respironics outlines, i was given no date when corrections would be made and was not offered a safe replacement machine.Unless a miracle occurs in the next few hours, i will be forced to hook my daughter up to this bipap which, rather than being lifesaving, now sounds like the "machine of death" based on philips respironics list of the dangers involved.Fda safety report id# (b)(4).

• Brand Name: DREAMSTATION S/T
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12348305
• MDR Text Key: 267752161
• Report Number: MW5103364
• 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: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/19/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other; Required Intervention; Disability
• Patient Age: 25 YR
• Patient Weight: 56