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

Device Problem No Apparent Adverse Event (3189)

Patient Problems Breast Cancer (1759); Unspecified Respiratory Problem (4464)

Event Date 07/27/2023

Event Type  Injury  

Event Description

The manufacturer received a voluntary medwatch (mw5120312).The manufacturer received information from the patient alleging lung cancer due to using the device.Patient reports receiving a replacement device due to the recall.Patient was upset and frustrated that they received a refurbished product instead of a new device.The patient then reports they were diagnosed with breast cancer and was instructed by her physician to stop using the refurbished device.The patient states that they now require supplemental oxygen 24/7, since they can no longer their bpap.Patient is discouraged with recall process and how long it took to receive a replacement device, only to have the replacement device be of poor quality.This report will capture the events related to the refurbished second device, supplemental oxygen and breast cancer.At this time, no further investigation can be performed.The device has not yet been returned to the manufacturer for evaluation.If any additional information is received, a follow up report will be filed.

Manufacturer Narrative

H3 other text : device not returned to manufacturer.

• Brand Name: 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: 17782717
• MDR Text Key: 323856087
• Report Number: 2518422-2023-23894
• 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: 09/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/28/2023
• 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): Life Threatening