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

Device Problem Degraded (1153)

Patient Problems Hypoxia (1918); Pneumonia (2011); Respiratory Failure (2484); Heart Failure/Congestive Heart Failure (4446); Unspecified Kidney or Urinary Problem (4503)

Event Date 11/13/2023

Event Type  Death  

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 information alleging kidney disease/toxicity and heart failure; respiratory failure; pneumonia; hypoxia and death.Medical intervention was not specified.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

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 information alleging kidney disease/toxicity and heart failure; respiratory failure; pneumonia; hypoxia and death.Medical intervention was not specified.Additional information is needed for further clarification and assessment of the reported allegation.However, at this time we are unable to obtain additional information due to lack of customer contact information.If pertinent information becomes available to the manufacturer at a later date, an addendum to this report will be filed.

Manufacturer Narrative

The manufacturer previously reported information 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 information alleging kidney disease/toxicity and heart failure; respiratory failure; pneumonia; hypoxia and death.Medical intervention was not specified.Additional information was received that thus far testing of the sound abatement foam has shown no evidence to suggest any potential exposure to foam vocs/particulates would result in any serious harm or death.Therefore, based on available information the reported death is assessed as not related to the device in this case.Currently we are unable to obtain additional information due to lack of customer contact information.If pertinent information becomes available to the manufacturer at a later date, an addendum to this report will be filed.

• 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: 17819789
• MDR Text Key: 324290733
• Report Number: 2518422-2023-24510
• 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: Other,Company Representative
• 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: 09/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/13/2023
• 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: Z-1974-2021
• Patient Sequence Number: 1
• Patient Outcome(s): Death