MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION AUTO BIPAP W/HUM/CELL, DOM; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DSX700H11C

Device Problem Increase in Pressure (1491)

Patient Problem Atrial Fibrillation (1729)

Event Date 02/09/2021

Event Type  malfunction  

Event Description

A user with an existing medical history of atrial fibrillation alleged the inspiratory pressure on his bi-level positive airway pressure (bipap) device increased suddenly during use, resulting in an episode of atrial fibrillation and admission to a hospital overnight for observation.The manufacturer received the device for investigation and could not confirm the allegation the device inspiratory pressure increased above the prescribed pressure.There were no operational issues, and the device passed all testing.The manufacturer concludes the device did not malfunction as alleged, and that no further action is necessary.

• Brand Name: DREAMSTATION AUTO BIPAP W/HUM/CELL, DOM
• 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: adam price ; 312 alvin drive; new kensington, PA 15068 ; 7243349303
• MDR Report Key: 11400253
• MDR Text Key: 234308191
• Report Number: 2518422-2021-00551
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959025691
• UDI-Public: 00606959025691
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/02/2021

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: DSX700H11C
• Device Catalogue Number: DSX700H11C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2021
• Initial Date FDA Received: 03/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2017
• 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): Hospitalization
• Patient Age: 67 YR