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

Model Number DEX900S13

Device Problem Degraded (1153)

Patient Problems Dysphagia/ Odynophagia (1815); Dyspnea (1816); Extreme Exhaustion (1843); Headache (1880); Nausea (1970)

Event Date 04/10/2024

Event Type  Death  

Event Description

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 received information alleging exhaustion, nausea, headaches, shortness of breath, choking attacks, difficulty swallowing and death.In addition, patient alleges filters were completely black every morning.There was no report of medical intervention.No additional information can be requested at this time.The manufacturer was made aware of this complaint through a representative of the customer.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.

Manufacturer Narrative

H3 other text : device not returned to manufacturer.

Manufacturer Narrative

Corrected data: evaluation code grid: from device not returned to type of investigation not yet determined.Evaluation results code grid: from no findings available to results pending completion of investigation conclusion code grid: from cause not established to conclusion not yet available.

• Brand Name: DREAMSTATION AUTOSV, DE
• 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: melissa rosko ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 19145264
• MDR Text Key: 340615346
• Report Number: 2518422-2024-19758
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K090539
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DEX900S13
• Device Catalogue Number: DEX900S13
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/09/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1973-2021
• Patient Sequence Number: 1
• Patient Outcome(s): Death