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

Model Number DSX700H11C

Device Problems Contamination (1120); Degraded (1153)

Patient Problems Headache (1880); Red Eye(s) (2038); Speech Disorder (4415); Dry Mouth (4485); Swelling/ Edema (4577)

Event Date 08/05/2020

Event Type  Injury  

Event Description

The manufacturer received voluntary medwatch (mw5104779) alleging an issue related to a bi-level positive airway pressure (bipap) device.The manufacturer received information alleging redness and swelling on the face at left side and redness of the eye, hoarseness, dry throat, headache.Medical intervention was prescribed medications.Despite of multiple attempts the device has not yet returned to the manufacturer for evaluation.At this time, no further investigation can be performed.If any additional information is received, a follow-up report will be filed.

Manufacturer Narrative

The manufacturer received voluntary medwatch (mw5104779) alleging an issue related to a bi-level positive airway pressure (bipap) device.The manufacturer received information alleging redness and swelling on the face at left side and redness of the eye, hoarseness, dry throat, headache.Medical intervention was prescribed medications.The device was returned to the manufacturer's quality product investigation laboratory for investigation ((b)(6) 2023).The device was evaluated on ((b)(6) 2023) and the manufacturer visually inspected the external and internally part of the device and found device missing accessory port flip door, sd card, and filter.The device's event logs were downloaded and reviewed by manufacturer.The manufacturer found no error codes.The manufacturer applied power to the device and verified airflow.The manufacturer concludes there was no evidence of sound abatement foam degradation, but a dust/dirt contamination and fibers found on the blower casing/impeller, blower box, and within bottom enclosure was inconsistent with degraded sound abatement foam contamination being from an external source.Section h6 is 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: 15430048
• MDR Text Key: 299991709
• Report Number: 2518422-2022-81046
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959025691
• UDI-Public: 00606959025691
• 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: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2022
• 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: DSX700H11C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2020
• 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