MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP SYNCHRONY AVAPS; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number BR1169S

Device Problems Contamination (1120); Unexpected Shutdown (4019)

Patient Problem Insufficient Information (4580)

Event Date 10/05/2021

Event Type  Death  

Event Description

The manufacturer received information alleging the bipap synchrony was not working.The patient was hospitalized and expired at the hospital.The investigation is still ongoing.A follow up report will be submitted when the manufacturer has completed the investigation.

Manufacturer Narrative

Additional information was received and section b5 should be reported as: the manufacturer previously received an information alleging the bipap synchrony was not working.The patient was hospitalized and expired at the hospital.The device was returned to the manufacturer's quality product investigation laboratory for investigation.The manufacture inspected externally observed that no evidence of sound abatement foam degradation.There was secondary findings of indeterminate contamination observed on and under ui knob.The dust, fiber and indeterminate contaminate observed throughout the airpath all likely from sources external to the devices.The external investigation noted minor wear and tear as well as moderate contamination on and under the ui knob, in the filter recess and in various crevices on all surface of the device.The internal investigation found dust and fiber contamination throughout the interior of the device.Dark particulate observed not consistent with foam degradation in blower box and air inlet seal.And indeterminate yellowish amber contamination was observed on the air inlet seal.The device's event logs were downloaded and reviewed by manufacturer.The manufacturer found no error codes.The manufacturer concludes there was no evidence of sound abatement foam degradation.The manufacturer observed dust, fiber contamination and water marks in the device and are consistent with being from an external source.

• Brand Name: BIPAP SYNCHRONY AVAPS
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• 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: 13062301
• MDR Text Key: 283491887
• Report Number: 2518422-2021-08583
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K092818
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/06/2023

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
• Device Model Number: BR1169S
• Device Catalogue Number: BR1169S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 10/06/2021
• Initial Date FDA Received: 12/22/2021
• Supplement Dates Manufacturer Received: 12/06/2022
• Supplement Dates FDA Received: 11/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization