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

Device Problem Degraded (1153)

Patient Problems Bacterial Infection (1735); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2022

Event Type  Injury  

Manufacturer Narrative

H3 other text : device not returned to manufacturer.

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 (mw5115029).The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.There was no report of serious injury or patient harm.There was no medical intervention required by the patient.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The manufacturer previously received information from voluntary medwatch (mw5115029) as product problem.After further review, the manufacturer concluded it as serious injury.In box b, product problem was updated to adverse event and product problem and describe event or problem should be reported as: 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 patient has alleged to experiencing flare of the sinusitis and persistent staph aureus infection.The reported events of sinusitis and persistent staph aureus infection of the patient and its reported severity were reviewed by the manufacture's clinical expert.These events are assessed as not related to the device in this case.Based on the available information, the manufacture concludes no further action is necessary.The patient reported of chronic sinusitis requiring 3 nasal surgeries and ongoing nasal rinses with antibiotics.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.In box h, type of reported complaint and health impact code was updated to reflect serious injury.

• Brand Name: PHILIPS DREAMSTATION CPAP
• 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: 17057179
• MDR Text Key: 316615374
• Report Number: 2518422-2023-12802
• 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: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2023
• 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: 11/17/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: RES 88058
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention