MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP PRO BIFLEX; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DS660TS

Device Problem Degraded (1153)

Patient Problems Dyspnea (1816); Headache (1880); Dizziness (2194); Chronic Obstructive Pulmonary Disease (COPD) (2237); Choking (2464); Unspecified Respiratory Problem (4464); Dry Mouth (4485); Unspecified Gastrointestinal Problem (4491)

Event Date 09/18/2023

Event Type  malfunction  

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 from the patient alleging that the patient has respiratory tract irritation, dizziness, headache, lung disease, chronic obstructive pulmonary disease, dry mouth, choking while use of the machine, coughing, acid reflux, breathing problems.No medical intervention was specified.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.

Manufacturer Narrative

H3 other text : device not returned to the manufacturer.

Manufacturer Narrative

The manufacturer previously reported in box b: adverse event or product problem as adverse event which is updated to product problem due on pms decision.Also in box h: device manufacturers type of reported complaint is also updated to product problem.Also the health impact grid is updated accordingly.

• Brand Name: BIPAP PRO BIFLEX
• 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: 18400000
• MDR Text Key: 331412790
• Report Number: 2518422-2023-37973
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959005969
• UDI-Public: 00606959005969
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131982
• 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

• Date FDA Received: 12/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: DS660TS
• Device Catalogue Number: DS660TS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/18/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/06/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1974-2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other