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

Model Number DSX900S11

Device Problem Degraded (1153)

Patient Problems High Blood Pressure/ Hypertension (1908); Dizziness (2194); Swelling/ Edema (4577)

Event Date 04/28/2023

Event Type  malfunction  

Event Description

A device was returned to a philips service center in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.During the evaluation of the device at the philips service center, the device was visually inspected, and no problem found.The unit not needed for internal stock and was scrapped.

• Brand Name: DREAMSTATION BIPAP 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 place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 17595627
• MDR Text Key: 322420933
• Report Number: 2518422-2023-20400
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090539
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: DSX900S11
• Device Catalogue Number: DSX900S11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2023
• Date Manufacturer Received: 04/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: RES 88058
• Patient Sequence Number: 1