MAUDE Adverse Event Report: RESPIRONICS, INC. REP DREAMSTATION AUTO BIPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DSX700S11F

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

Patient Problems Cancer (3262); Unspecified Respiratory Problem (4464)

Event Date 10/12/2023

Event Type  Injury  

Manufacturer Narrative

H3 other text : device has not been returned to the manufacturer.

Event Description

The manufacturer became aware of a rep dreamstation auto bipap device not working and it is broken.The patient alleged lung disease and cancer.Medical intervention was not specified by the patient.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.

• Brand Name: REP DREAMSTATION AUTO BIPAP
• 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: 19005929
• MDR Text Key: 338932515
• Report Number: 2518422-2024-16215
• Device Sequence Number: 1
• Product Code: BZD
• 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
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX700S11F
• Device Catalogue Number: DSX700S11F
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/23/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other