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

Model Number DSX700T11C

Device Problem Degraded (1153)

Patient Problem Pulmonary Edema (2020)

Event Date 12/10/2021

Event Type  malfunction  

Event Description

The manufacturer received information alleging a bilevel positive airway pressure (bipap) device's sound abatement foam became degraded and caused a patient to develop fluid in lungs.The patent was prescribed medication in response to the reported event.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.

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 a cpap device's sound abatement foam became degraded and caused a patient to develop fluid in lungs.The patient was prescribed medication in response to the reported event.The device was returned to the manufacturer's product investigation laboratory for investigation.An internal visual inspection was performed by the manufacturer.The manufacturer found evidence of sound abatement foam degradation.The humidifier was returned to the manufacturer's product investigation laboratory for evaluation.The manufacturer found evidence of sticky residue on the front panel of humidifier and back panel of base unit.The manufacturer concludes evidence of sound abatement foam degradation or breakdown.After further review, the manufacturer confirmed that the previously submitted report was incorrectly filed as adverse event which should have been filed as product problem only, and there was no report of serious or permanent patient harm or injury.Section b1,b2, d9, g3, h1, h6 has been updated / corrected.

• 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 15206 ; 2673970028
• MDR Report Key: 13176862
• MDR Text Key: 283315693
• Report Number: 2518422-2022-00324
• Device Sequence Number: 1
• Product Code: BZD
• 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
• Report Date: 02/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX700T11C
• Device Catalogue Number: DSX700T11C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 01/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: RES 88058
• Patient Sequence Number: 1
• Treatment: HUMIDIFIER DSXHCP SN- (B)(6).
• Patient Outcome(s): Other