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

Model Number DSX700H11C

Device Problem Degraded (1153)

Patient Problems Fatigue (1849); Nausea (1970); Dizziness (2194); Unspecified Heart Problem (4454); Cough (4457); Epistaxis (4458)

Event Date 03/20/2023

Event Type  malfunction  

Event Description

The manufacturer received a voluntary medwatch (mw5145628) regarding the field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received information alleging heart palpitations, coughing, congestion, nosebleed, dizziness, nausea, tiredness, and lack of focus.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.

Manufacturer Narrative

The manufacturer previously reported information in reference to a voluntary medwatch (mw5145628) regarding the field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received information alleging heart palpitations, coughing, congestion, nosebleed, dizziness, nausea, tiredness, and lack of focus.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.After further review, this report is now being filed as a product problem only instead of an adverse event and product problem as previously reported.Section h6, health impact code was updated to reflect this decision.The recall z number was updated.

• Brand Name: DREAMSTATION AUTO BIPAP
• 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: 17886957
• MDR Text Key: 325119199
• Report Number: 2518422-2023-25847
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959022652
• UDI-Public: 00606959022652
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131982
• 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: 10/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX700H11C
• Device Catalogue Number: DSXHCP
• Device Lot Number: H2091633043B95
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/09/2023
• 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): Other