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

Model Number DSX700H11

Device Problems Degraded (1153); Smoking (1585); Sparking (2595)

Patient Problems Anemia (1706); Hyperglycemia (1905); High Blood Pressure/ Hypertension (1908); Chronic Obstructive Pulmonary Disease (COPD) (2237); Cancer (3262)

Event Date 04/05/2022

Event Type  Injury  

Event Description

The manufacturer received information alleging an issue related to a bi-level positive airway pressure (bipap) device's sound abatement foam.The user also alleged the device was smoking and there was a large spark when the side plug attached to machine was pulled out.The device reportedly no longer functions.The user also alleges being diagnosed with chronic obstructive pulmonary disease, lung cancer, hypertension, diabetes and anemia while using this device.Medical intervention was not specified.The manufacturer requested return of the device and accessories for investigation.The manufacturer's investigation is ongoing.Upon completion of the manufacturer's investigation, a follow up report will be filed.

Manufacturer Narrative

The manufacturer received information alleging an issue related to a bi-level positive airway pressure (bipap) device's sound abatement foam.The user also alleged the device was smoking and there was a large spark when the side plug attached to machine was pulled out.The device reportedly no longer functions.The patient also alleged being diagnosed with chronic obstructive pulmonary disease, lung cancer, hypertension, diabetes and anemia while using this device.Medical intervention was not specified.The device was returned to the manufacturer's service center for further evaluation.  the device was evaluated.There was no mention of visual findings to the external part of the device.  the internal aspect of the device was inspected.The device powered on and airflow was confirmed.The device's downloaded logs were reviewed by the manufacturer.There were no errors found.  the manufacturer concludes that they could not confirm the customer's allegation and there was no visible foam degradation and unit is scrapped.Section d8, d9, h2, h3 and h6 were 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 15206 ; 2673970028
• MDR Report Key: 14241997
• MDR Text Key: 290391990
• Report Number: 2518422-2022-13262
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959022539
• UDI-Public: 00606959022539
• 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: 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX700H11
• Device Catalogue Number: DSX700H11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 01/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2016
• 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