MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION BIPAP; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Device Problem Degraded (1153)

Patient Problems Cough (4457); Epistaxis (4458); Unspecified Respiratory Problem (4464)

Event Date 08/09/2021

Event Type  malfunction  

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 patient alleges coughing, nose irritation, and bleeding from using the device.There is no allegation of serious or permanent harm or injury.The patient required no medical intervention.The device has not yet been returned to the manufacturer for evaluation and there is no contact information for the initial reporter to gain additional information on the device.At this time, no further investigation can be performed.If any additional information is received, a follow-up report will be filed.

Manufacturer Narrative

H3 other text : the device has not been returned to the manufacturer.

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 patient alleges coughing, nose irritation, and bleeding from using the device.There is no allegation of serious or permanent harm or injury.The patient required no medical intervention.The device has not yet been returned to the manufacturer for evaluation and there is no contact information for the initial reporter to gain additional information on the device.At this time, no further investigation can be performed.If any additional information is received, a follow-up report will be filed.On the initial report, the reporter country was omitted.It has been corrected on this report.

• Brand Name: DREAMSTATION BIPAP
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• 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: 17667438
• MDR Text Key: 322822754
• Report Number: 2518422-2023-21504
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090539
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/09/2021
• Initial Date FDA Received: 08/31/2023
• Supplement Dates Manufacturer Received: 08/09/2021
• 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