MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC DREAMSTATION BIPAP AUTOSV; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number DSX900S11F

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Apnea (1720); Asthma (1726); Nasal Obstruction (2466); Sleep Dysfunction (2517)

Event Date 10/20/2022

Event Type  Injury  

Manufacturer Narrative

H3 other text : device not returned to manufacturer.

Event Description

The manufacturer was contacted by the patient after she received her replacement bipap device.The patient alleges nasal obstruction, and sleep dysfunction.The patient also alleges smelling an odor from the replacement device.The patient stated she visited her doctor but did not specify any medical interventions.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 a patient contacted the manufacturer after she received her replacement bipap device.The patient alleged nasal obstruction, and sleep dysfunction.The patient also alleged smelling an odor from the replacement device.The patient stated she visited her doctor but did not specify any medical interventions.The manufacturer also previously reported the patient stated her original bipap was recalled, and that the replacement device was received, and she had health problems starting the very first night she used it.The user reported that her nasal passages were closed, "before i even got to sleep", and that the device had a smell/odor that was, "like a glue smell".She was awoken during the night due to an asthma exacerbation and reported that this had never happened to her before.The patient has central sleep apnea due to a brain injury.She states she feels like she has a sinus infection and, "i don't know who to contact" regarding the machine problems.She states that using the humidifier that is part of the device makes her symptoms even worse.She reports not sleeping well since she cannot use her replacement machine.After review, it was determined section h1, type of reportable event, should have been reported as a serious injury, and not other.Repeated attempts to have the device and components returned for evaluation and investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information.The manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.Section h1 and h6 updated in this report.

Event Description

The manufacturer was contacted by the patient after she received her replacement bipap device.The patient states her original bipap was recalled, and that the replacement device was received on or about (b)(6) 2022, and she had health problems starting the very first night she used it.She reports that her nasal passages were closed, "before i even got to sleep", and that the device had a smell/odor that was, "like a glue smell".She was awoken during the night due to an asthma exacerbation and reports that this had never happened to her before.The patient has central sleep apnea due to a brain injury.She states she feels like she has a sinus infection and, "i don't know who to contact" regarding the machine problems.She states that using the humidifier that is part of the device makes her symptoms even worse.She reports not sleeping well since she cannot use her replacement machine.

Manufacturer Narrative

The manufacturer was previously contacted by the patient after she received her replacement bipap device.The patient alleges nasal obstruction, and sleep dysfunction.The patient also alleges smelling an odor from the replacement device.The patient stated she visited her doctor but did not specify any medical interventions.Addition information added to section b5, describe event/ problem statement: the manufacturer was contacted by the patient after she received her replacement bipap device.The patient states her original bipap was recalled, and that the replacement device was received on or about (b)(6) 2022, and she had health problems starting the very first night she used it.She reports that her nasal passages were closed, "before i even got to sleep", and that the device had a smell/odor that was, "like a glue smell".She was awoken during the night due to an asthma exacerbation and reports that this had never happened to her before.The patient has central sleep apnea due to a brain injury.She states she feels like she has a sinus infection and, "i don't know who to contact" regarding the machine problems.She states that using the humidifier that is part of the device makes her symptoms even worse.She reports not sleeping well since she cannot use her replacement machine.Section h, patient outcome code grid (2) had additional codes of asthma, apnea, and sinusitis added.The above information was omitted in error during time of first report.

• Brand Name: DREAMSTATION BIPAP AUTOSV
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 1001 murry ridge lane; ste a; murrysville PA 15668
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 1001 murry ridge lane; ste a; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 17183544
• MDR Text Key: 317916289
• Report Number: 2518422-2023-13990
• 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
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX900S11F
• Device Catalogue Number: DSX900S11F
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/06/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other