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

Device Problem Failure to Power Up (1476)

Patient Problems Dyspnea (1816); Fatigue (1849)

Event Date 09/04/2023

Event Type  Injury  

Event Description

The manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received voluntary medwatch (mw5145821).The patient has alleged to had heart surgery and the dreamstation2 cpap machine stopped working just after coming from hospital, with exhaustion in the recovery phase.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

Due to the manufacturer not receiving the device information, the following are possible recall z numbers: z-1972-2021 , z-1974-2021 , z-1973-2021 h3 other text : device not returned to manufacturer.

Manufacturer Narrative

The manufacturer was contacted in reference to the dreamstation2 cpap device.The manufacturer received voluntary medwatch (mw5145821).The patient has alleged to had heart surgery and the dreamstation2 cpap machine stopped working just after coming from hospital, with exhaustion in the recovery phase.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.Previously submitted report was incorrectly filed with incorrect describe event or problem.In this report the describe event is corrected and updated.

Event Description

The manufacturer was contacted in reference to the dreamstation 2 cpap device.The manufacturer received voluntary medwatch (mw5145821).The patient has alleged to had heart surgery and the dreamstation2 cpap machine stopped working just after coming from hospital, with exhaustion in the recovery phase.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• Brand Name: PHILIPS CPAP DEVICE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 17966621
• MDR Text Key: 326064293
• Report Number: 2518422-2023-26801
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200480
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/02/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization