MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP A30; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number 1111143

Device Problem No Audible Alarm (1019)

Patient Problem Insufficient Information (4580)

Event Date 01/06/2023

Event Type  Death  

Manufacturer Narrative

Device in possession of the distributor.

Event Description

The manufacturer received information alleging a patient expired while using a bipap a30 device.The device's tubing was found disconnected and there was no alarm from the device.It is uncertain if the device's alarm was enabled in the device's settings.The investigation is still ongoing.The device is currently in the distributor's possession.The manufacturer will submit a follow up report when the manufacturer has completed the investigation.

Manufacturer Narrative

The manufacturer previously received information alleging a patient expired while using a bipap a30 device.The device's tubing was found disconnected and there was no alarm from the device.It is uncertain if the device's alarm was enabled in the device's settings.The device was returned to the manufacturer¿s product investigation laboratory for further evaluation.The device was visually inspected and found no visual defects.The manufacturer confirmed there was no evidence of sound abatement foam degradation.The customer compliant of device not alarming could not be confirmed.The device operated properly on the existing software version 3.4.The device¿s downloaded event log was reviewed by the manufacturer.The manufacturer confirmed that the unit got into multiple corrupt sd card entries.The manufacturer tested the device and found the device to operates properly.

• Brand Name: BIPAP A30
• 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 15208 ; 4125423300
• MDR Report Key: 16189144
• MDR Text Key: 307556899
• Report Number: 2518422-2023-01698
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K113053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1111143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death