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

Model Number DSX900H11C

Device Problem Degraded (1153)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/10/2023

Event Type  Death  

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 that the patient passed away in his sleep.Medical intervention was not specified.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 information 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 that the patient passed away in his sleep.Medical intervention was not specified.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.On the previously submitted report, wrong outcome attributed to ae was selected.It is correct on this report.

Manufacturer Narrative

The manufacturer previously reported information 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 that the patient passed away in his sleep.Medical intervention was not specified.Additional information includes that the results of an internal investigation conclude the following: the customer makes no allegation of any specific device malfunction, use error, failure, labeling, or other deficiency that is relevant to the death reported.Although exposure to particulates and vocs could potentially result in mild to moderate respiratory irritation, it would not be to the degree of serious harm/injury/death.Also, thus far testing of the sound abatement foam has shown no evidence to suggest possible exposure to foam vocs/particulates would result in any serious harm or death.Therefore, based on available information at the time of the review, the reported death is assessed as not related to the device in this case.If further information becomes available, an additional report will be filed.The manufacturer concludes no further action is needed at this time.

• 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: 17849502
• MDR Text Key: 324657288
• Report Number: 2518422-2023-25115
• 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: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,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: Not provided
• Initial Date FDA Received: 10/01/2023
• Supplement Dates Manufacturer Received: 09/10/2023; 09/27/2023
• Supplement Dates FDA Received: 10/10/2023; 10/27/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/26/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1658-2022
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening
• Patient Age: 49 YR
• Patient Sex: Male