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

Model Number DSX700S11

Device Problems Contamination (1120); Degraded (1153)

Patient Problems Dyspnea (1816); Pulmonary Edema (2020); Unspecified Respiratory Problem (4464); Unspecified Hepatic or Biliary Problem (4493); Unspecified Kidney or Urinary Problem (4503)

Event Date 11/30/2021

Event Type  malfunction  

Event Description

The manufacturer received information alleging a bipap device's sound abatement foam became degraded and caused lung, liver and kidney issues, difficulty breathing and fluid in the lungs.The patient did receive medical intervention and reported to have been hospitalized.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.

Manufacturer Narrative

The manufacturer received information alleging a bipap device's sound abatement foam became degraded and caused lung, liver and kidney issues, difficulty breathing and fluid in the lungs.The patient did receive medical intervention and reported to have been hospitalized.The device was returned to the manufacturer's product investigation laboratory for investigation.An internal visual inspection of the device was completed by the manufacturer.The manufacturer found evidence of an unknown dust contaminant and an unknown dark contaminant on the front panel, an unknown dark contaminant was on the blower box, an unknown contaminant was on the blower, consistent with liquid ingress, an unknown dust contaminant on the blower seal, a dark unknown contaminant on the rear panel, and an unknown contaminant on the bottom enclosure, a keratin-like substance on the blower box outlet.The manufacturer also found evidence of liquid ingress on the blower after removing it from the blower box, along with liquid ingress to the blower box.The manufacturer found no evidence of sound abatement foam degradation/breakdown.The device's event logs were downloaded and reviewed.The manufacturer found instances of e-22 and e-200.The manufacturer concludes there was evidence multiple contamination on the device.The manufacturer confirmed there was no evidence of sound abatement foam degradation/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.Section b1, b2, d9, g3 and h6 has been updated/corrected in this report.

Manufacturer Narrative

The manufacturer previously did not select section h1-type of reportable event as malfunction, and it has been updated in this report.

• 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: 12954871
• MDR Text Key: 281873678
• Report Number: 2518422-2021-07736
• 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,Followup
• Report Date: 10/25/2023

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
• Device Model Number: DSX700S11
• Device Catalogue Number: DSX700S11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 11/30/2021
• Initial Date FDA Received: 12/07/2021
• Supplement Dates Manufacturer Received: 01/24/2023; 01/24/2023
• Supplement Dates FDA Received: 02/17/2023; 10/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2018
• 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
• Patient Outcome(s): Other; Hospitalization