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

Device Problem Degraded (1153)

Patient Problems Cardiac Arrest (1762); Hypoxia (1918); Cognitive Changes (2551); Unspecified Respiratory Problem (4464)

Event Date 04/22/2022

Event Type  Death  

Event Description

The manufacturer received information alleging a device's sound abatement foam became degraded and caused the patient to have respiratory issues, cardiac arrest, hypoxemia and loss of cognitive function resulting in patient's death.The patient was reportedly hospitalized in response to the event.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 a device's sound abatement foam allegedly became degraded and caused the patient to have respiratory issues, cardiac arrest, hypoxemia and loss of cognitive function resulting in patient's death.The patient was reportedly hospitalized in response to the event.The manufacturer previously did not include the voluntary medwatch report reference number mw5109345 in the initial report.

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 received information alleging have respiratory issues, cardiac arrest, hypoxemia and loss of cognitive function resulting in patient's death related to a cpap device's sound abatement foam became degraded and caused the patient to have kidney cancer.The medical intervention that the patient received in response to the event is currently unknown.Repeated attempts to have the device and components returned for evaluation and investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information.The manufacturer is submitting an updated report at this time.If pertinent information becomes available to the manufacturer at a later date a follow-up report will be filed.The reported event of death secondary to respiratory failure was reviewed by the pms clinical expert.This event is assessed as not related to the device in this case.

• Brand Name: REMSTAR PRO
• 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 15206 ; 2673970028
• MDR Report Key: 15185771
• MDR Text Key: 297456800
• Report Number: 2518422-2022-70828
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113068
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 06/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/28/2022
• Initial Date FDA Received: 08/08/2022
• Supplement Dates Manufacturer Received: 09/12/2022; 10/19/2022
• Supplement Dates FDA Received: 09/13/2022; 06/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Death