MAUDE Adverse Event Report: RESPIRONICS, INC. DS2ADV AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DSX520T11C

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dry Eye(s) (1814); Epistaxis (4458)

Event Date 07/17/2023

Event Type  malfunction  

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 his eyes get dry and his nose bleed.That patient states " after using it for 4 hours it gets very dry hard to shallow and used biotin throat spray.6 drops on the left eye and 4 drops on the left.Ayr for his nose and for his refreshed eye drops for his eyes".There is no allegation of serious or permanent harm or injury.Medical intervention was required by the patient.The patient was provided with an antibiotic.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 patient alleges his eyes get dry and his nose bleed.That patient states " after using it for 4 hours it gets very dry hard to shallow and used biotin throat spray.6 drops on the left eye and 4 drops on the left.Ayr for his nose and for his refreshed eye drops for his eyes".There is no allegation of serious or permanent harm or injury.Medical intervention was required by the patient.The patient was provided with an antibiotic.The incorrect verbiage was included in the b5 as the device is out of scope for the recall.The b5 is now updated with the correct verbiage.The manufacturer received information where "the patient alleges his eyes get dry and his nose bleed.That patient states " after using it for 4 hours it gets very dry hard to shallow and used biotin throat spray.6 drops on the left eye and 4 drops on the left.Ayr for his nose and for his refreshed eye drops for his eyes".There is no allegation of serious or permanent harm or injury.Medical intervention was required by the patient.The patient was provided with an antibiotic".The device has not yet been returned to the manufacturer for evaluation.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.

Event Description

The manufacturer received information where "the patient alleges his eyes get dry and his nose bleed.That patient states " after using it for 4 hours it gets very dry hard to shallow and used biotin throat spray.6 drops on the left eye and 4 drops on the left.Ayr for his nose and for his refreshed eye drops for his eyes".There is no allegation of serious or permanent harm or injury.Medical intervention was required by the patient.The patient was provided with an antibiotic".

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 patient alleges his eyes get dry and his nose bleed.That patient states " after using it for 4 hours it gets very dry hard to shallow and used biotin throat spray.6 drops on the left eye and 4 drops on the left.Ayr for his nose and for his refreshed eye drops for his eyes".There is no allegation of serious or permanent harm or injury.Medical intervention was required by the patient.The patient was provided with an antibiotic.The incorrect verbiage was included in the b5 as the device is out of scope for the recall.The b5 is now updated with the correct verbiage.The manufacturer received information where "the patient alleges his eyes get dry and his nose bleed.That patient states " after using it for 4 hours it gets very dry hard to shallow and used biotin throat spray.6 drops on the left eye and 4 drops on the left.Ayr for his nose and for his refreshed eye drops for his eyes".There is no allegation of serious or permanent harm or injury.Medical intervention was required by the patient.The patient was provided with an antibiotic".The device has not yet been returned to the manufacturer for evaluation.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.The previously submitted report should have been recorded as not reportable as there was no mention of recall, no particle allegation, no evaluation of particles found, and the allegation of nosebleed and dry eyes is not a serious injury.Section h6 device problem code was updated, there was no allegation of degradation.

• Brand Name: DS2ADV AUTO CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• 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: 17682273
• MDR Text Key: 322619249
• Report Number: 2518422-2023-21616
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200480
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX520T11C
• Device Catalogue Number: DSX520T11C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/31/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/29/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Sex: Male