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

Model Number DSX1030H11C

Device Problem Degraded (1153)

Patient Problems Dyspnea (1816); Hypoxia (1918); Nausea (1970); Choking (2464); Cough (4457); Unspecified Respiratory Problem (4464)

Event Date 08/27/2021

Event Type  malfunction  

Manufacturer Narrative

H3 other text : device not returned to the 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 the device would randomly shut off during the night which would stop the air flow.The patient states the device was not detecting when she wasn't breathing and that her oxygen stats would drop low while using the device.The patient alleges that when using the device to much she gets a wet cough and feels like she has a lot of chest pressure/pneumonia, nausea and feels dried out.Patient states she wakes up multiple times during the night and would feel like she's choking or suffocating.There was no allegation of serious or permanent harm or injury.Medical intervention was not specified.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 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 alleging the device would randomly shut off during the night which would stop the air flow.The patient states the device was not detecting when she wasn't breathing and that her oxygen stats would drop low while using the device.The patient alleges that when using the device to much she gets a wet cough and feels like she has a lot of chest pressure/pneumonia, nausea and feels dried out.Patient states she wakes up multiple times during the night and would feel like she's choking or suffocating.There was no allegation of serious or permanent harm or injury.Medical intervention was not specified.On the previously submitted report, the "type of reportable event" and "outcomes attributed to ae" in section b.Were both reported incorrectly.It is corrected 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 alleging the device would randomly shut off during the night which would stop the air flow.The patient states the device was not detecting when she wasn't breathing and that her oxygen stats would drop low while using the device.The patient alleges that when using the device to much she gets a wet cough and feels like she has a lot of chest pressure/pneumonia, nausea and feels dried out.Patient states she wakes up multiple times during the night and would feel like she's choking or suffocating.Medical intervention was not specified.During a pms clinical expert review, it was determined that this event is assessable for injury or relatedness based on the information provided at this time.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 ST
• 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: 17051699
• MDR Text Key: 316428638
• Report Number: 2518422-2023-12751
• Device Sequence Number: 1
• Product Code: MNS
• UDI-Device Identifier: 00606959045590
• UDI-Public: 00606959045590
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102465
• 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

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: DSX1030H11C
• Device Catalogue Number: DSX1030H11C
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/27/2021
• Initial Date FDA Received: 06/02/2023
• Supplement Dates Manufacturer Received: 06/20/2023; 08/16/2023
• Supplement Dates FDA Received: 06/20/2023; 08/28/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/04/2021
• 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