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

Device Problem Degraded (1153)

Patient Problems Asthma (1726); Rash (2033)

Event Date 07/24/2021

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 information alleging severe asthma and rash on his face around mask.No medical intervention was specified by the patient.  the device has not yet been returned to the manufacturer for evaluation. three attempts to have the device returned for evaluation and investigation were unsuccessful. at this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.

Manufacturer Narrative

The manufacturer was previously 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 severe asthma and rash on patient's face around mask.No medical intervention was specified by the patient.  due to clinical expert decision, the allegation of asthma will now be classified as serious injury only, not related to a product problem.The rash is categorized as a non-serious injury, hence the device not contributing to a serious injury.Box b: adverse event or product problem was updated from "both" to "adverse event" only.The device has not yet been returned to the manufacturer for evaluation. three attempts to have the device returned for evaluation and investigation were unsuccessful. at this time, no further investigation can be performed.If any additional information is received, a follow up 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: 17503212
• MDR Text Key: 320828276
• Report Number: 2518422-2023-19374
• 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

• 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
• Initial Date Manufacturer Received: 07/24/2021
• Initial Date FDA Received: 08/10/2023
• Supplement Dates Manufacturer Received: 08/23/2023
• Supplement Dates FDA Received: 09/05/2023
• 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): Life Threatening