MAUDE Adverse Event Report: RESPIRONICS,INC DREAMSTATION BIPAP AUTOSV; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number DSX900H11C

Device Problem Degraded (1153)

Patient Problems Apnea (1720); Stroke/CVA (1770); Dyspnea (1816); Dry Mouth (4485)

Event Date 02/24/2022

Event Type  Injury  

Event Description

The manufacturer received information alleging an issue related to a bipap device's sound abatement foam.The patient alleged central and obstructive sleep apnea.The patient also alleged high risk for stroke due to not breathing.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The manufacturer previously reported an issue with a cpap device's sound abatement foam.The patient alleged central and obstructive sleep apnea.The patient also alleged high risk for stroke due to not breathing.The manufacturer has received the additional information alleging dry mouth.Section g3, h6 has been updated / corrected.

Manufacturer Narrative

The manufacturer was 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 previously received information alleged central and obstructive sleep apnea.The patient also alleged high risk for stroke due to not breathing and dry mouth.The reported event and its reported severity was reviewed by the manufacture's clinical expert.This reported event of obstructive and central sleep apnea and because of this an elevated risk for stroke.This information is not an allegation against the device.The patient also reports dry mouth and that their device is not working.Their device could have possibly caused or contributed to the reported event of dry mouth and device is not functioning and could also possibly be related to user error and improper humidification/tube temperature settings by the patient.Repeated attempts to have the device and components returned for evaluation and investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information.The manufacturer is submitting an updated report at this time.If pertinent information becomes available to the manufacturer at a later date, a follow-up report will be filed.Section h6 updated in this report.

• Brand Name: DREAMSTATION BIPAP AUTOSV
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• 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: 15107764
• MDR Text Key: 296654995
• Report Number: 2518422-2022-64055
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090539
• 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,Followup
• Report Date: 07/19/2023

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: DSX900H11C
• Device Catalogue Number: DSX900H11C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/24/2022
• Initial Date FDA Received: 07/26/2022
• Supplement Dates Manufacturer Received: 09/01/2022; 07/13/2023
• Supplement Dates FDA Received: 09/01/2022; 07/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2019
• 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