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

Model Number GBX900S15

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Cardiac Arrest (1762)

Event Date 12/10/2021

Event Type  Death  

Event Description

The manufacturer became aware that a user while on a dreamstation auto sv passed away.The wife was awoken by a machine alarm during the event.The coroner recorded the death as due to a sudden cardiac event.The dme stated the unit passed testing but wanted it send in for investigation.The device has not yet been returned for evaluation.The investigation is on-going.A final report will be sent when the investigation is complete.

Event Description

The manufacturer became aware that a user while on a dreamstation auto sv passed away.The wife was awoken by a machine alarm during the event.The coroner recorded the death as due to a sudden cardiac event.The dme stated the unit passed testing but wanted it send in for investigation.The device has not yet been returned for evaluation.The investigation is on-going.A final report will be sent when the investigation is complete.

Manufacturer Narrative

The manufacturer became aware that an end user while on a dreamstation auto sv passed away.The user's wife stated she was awakened by a machine alarm during the event.The coroner recorded the death as due to a sudden cardiac event.The dme stated the device passed testing but requested evaluation.The device was received by the manufacturer for investigation.There were no operational issues found, and the device functioned as designed.Data downloaded from the device indicated a low minute ventilation alarm did occur at the time of the event.Note the date of the event was incorrectly reported on the initial report and has been corrected.Based on the information available, the manufacturer concludes no further action is necessary.

• Brand Name: DREAMSTATION AUTOSV
• 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 plavce; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 13577193
• MDR Text Key: 285928654
• Report Number: 2518422-2022-05574
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K090539
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/27/2022

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: GBX900S15
• Device Catalogue Number: GBX900S15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2022
• Initial Date FDA Received: 02/22/2022
• Supplement Dates Manufacturer Received: 03/31/2022
• Supplement Dates FDA Received: 04/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2019
• 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
• Treatment: HUMIDIFIER -NO SN
• Patient Outcome(s): Death
• Patient Sex: Male