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

Model Number DSX900T11C

Device Problem Degraded (1153)

Patient Problems Dyspnea (1816); Numbness (2415)

Event Date 09/07/2021

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 patient alleges a suction feeling around the face, numbness of mouth and loss of breath/difficulty breathing, while using the device.Additionally, the patient states, that the alarm goes off saying low pressure.When actually, the pressure is showing high at 10 when it is usually around 6 or 7.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.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 patient alleges a suction feeling around the face, numbness of mouth and loss of breath/difficulty breathing while using the device.Additionally, the patient states that the alarm goes off saying low pressure when actually the pressure is showing high at 10 when it is usually around 6 or 7.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.After further review, this report is now being filed as both, an adverse event & product problem instead of a product problem.Section h6, health impact code was updated.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.

• 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: 17309559
• MDR Text Key: 319051135
• Report Number: 2518422-2023-15500
• 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: DSX900T11C
• Device Catalogue Number: DSX900T11C
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/07/2021
• Initial Date FDA Received: 07/12/2023
• Supplement Dates Manufacturer Received: 08/18/2023
• Supplement Dates FDA Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: RES 88058
• Patient Sequence Number: 1
• Patient Outcome(s): Other