MAUDE Adverse Event Report: RESPIRONICS, INC BIPAP S/T CSERIES; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number 1061457

Device Problem Degraded (1153)

Patient Problem Breast Cancer (1759)

Event Date 08/23/2021

Event Type  Injury  

Event Description

The manufacturer received information alleging a bipap device's sound abatement foam became degraded and caused breast cancer.The patient's medical intervention is unknown at this time.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res (b)(4).

Manufacturer Narrative

The manufacturer previously reported a bipap device's sound abatement foam became allegedly degraded and caused breast cancer.The patient's medical intervention is unknown at this time.Correction to section b1: product problem correction to section b2: other serious injury or important medical events.

Manufacturer Narrative

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 previously reported a bipap device's sound abatement foam became allegedly degraded and caused breast cancer.The patient's medical intervention is unknown at this time.Upon further review, the reported event of primary diagnosis of pulmonary fibrosis, history of diabetes and breast cancer and the patient using the device 24/7 - cannot be without the device was assessed as serious injury.

• Brand Name: BIPAP S/T CSERIES
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): RESPIRONICS, INC; 1001 murry ridge ln; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC; 1001 murry ridge ln; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 12388057
• MDR Text Key: 268845568
• Report Number: 2518422-2021-03606
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K102465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1061457
• Device Catalogue Number: 1061457
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: RES 88058
• Patient Sequence Number: 1
• Patient Outcome(s): Other