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

Model Number DSX900H11C

Device Problem Degraded (1153)

Patient Problems Unspecified Heart Problem (4454); Respiratory Insufficiency (4462)

Event Date 03/29/2023

Event Type  Injury  

Manufacturer Narrative

H3 other text : device not returned to manufacturer.

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 visualization of particles in the air path.In addition, the customer is alleging suffering from breathing and heart problems due to not being able to use the device.There was no indication of medical intervention.The patient reported cleaning their device with water and vinegar which is not an approved recommendation for cleaning the device.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 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 customer alleged acquiring congestive heart failure from using the device.There was no indication of medical intervention.The device has not yet been returned to the manufacturer for evaluation.Three attempts to have the device returned for evaluation and investigation were unsuccessful.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 previously reported 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 visualization of particles in the air path.In addition, the customer is alleging suffering from breathing and heart problems due to not being able to use the device.There was no indication of medical intervention.The patient reported cleaning their device with water and vinegar which is not an approved recommendation for cleaning the device.On the previously submitted follow up report, the "addtl narrative/corrected data" was inadvertently filled out incorrectly and submitted in error on 5/16/2023.The following information is incorrect regarding this reported case and was provided in error." the customer alleged acquiring congestive heart failure from using the device.There was no indication of medical intervention.Three attempts to have the device returned for evaluation and investigation were unsuccessful.At this time, no further investigation can be performed." at this time, there is no change to the manufacturer's investigation status.When the investigation is completed a follow up report will be submitted.

Manufacturer Narrative

The manufacturer previously reported 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 visualization of particles in the air path.In addition, the customer is alleging suffering from breathing and heart problems due to not being able to use the device.There was no indication of medical intervention.The patient reported cleaning their device with water and vinegar which is not an approved recommendation for cleaning the device.The device has not yet been returned to the manufacturer for evaluation.Three attempts to have the device returned for evaluation and investigation were unsuccessful.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.

Manufacturer Narrative

A corrected report is being filed as section b: adverse event or product problem, was reported as "both" on the initial report.It has been corrected on this report and selected as "product problem" only.In addition, "outcomes attributed to ae" is listed as "none".Section h, "type of reported complaint" was selected as "serious injury" on the initial report and has been updated to "product problem" on this correction 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 15208 ; 4125423300
• MDR Report Key: 16809803
• MDR Text Key: 313950807
• Report Number: 2518422-2023-09618
• 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: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup

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
• Initial Date Manufacturer Received: 03/29/2023
• Initial Date FDA Received: 04/25/2023
• Supplement Dates Manufacturer Received: 04/24/2023; 04/24/2023; 05/30/2023; 05/30/2023
• Supplement Dates FDA Received: 05/16/2023; 05/16/2023; 06/01/2023; 03/18/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/11/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: RES 88058
• Patient Sequence Number: 1
• Patient Outcome(s): Other