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

Model Number DSX900H11C

Device Problem Degraded (1153)

Patient Problems Dyspnea (1816); Myocardial Infarction (1969); Unspecified Respiratory Problem (4464)

Event Date 04/18/2023

Event Type  malfunction  

Manufacturer Narrative

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 difficulty breathing/shortness of breath, heart attack, lung issues.In addition, the device will not turn on/device is not functioning.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 was previously 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 difficulty breathing /shortness of breath, heart attack, lung issues.In addition, the device will not turn on/device is not functioning.Medical intervention was not specified.The manufacturer received new information that the patient has hired an attorney and additionally commented that device shuts off and, water not coming out.So the correction event description should be - the manufacturer received information alleging an issue related to a bipap device's sound abatement foam.The patient alleged difficulty breathing /shortness of breath and lung issues.There was no report of serious patient harm or injury.Due to potential litigation surrounding this case, no follow up can be performed at this time.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.After further investigation, it was determined that the allegation of symptoms of the patient are not related to the device and they are not serious injury.In this report box b and box h are updated.

• 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: 16812707
• MDR Text Key: 313986239
• Report Number: 2518422-2023-09661
• 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

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: 04/18/2023
• Initial Date FDA Received: 04/26/2023
• Supplement Dates Manufacturer Received: 04/18/2023
• Supplement Dates FDA Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/31/2019
• 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