MAUDE Adverse Event Report: RESPIRONICS, INC. REP DREAMSTATION AVAPS30; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number DSX1130S11F

Device Problem Degraded (1153)

Patient Problems Apnea (1720); Dyspnea (1816); Convulsion/Seizure (4406); Unspecified Respiratory Problem (4464)

Event Date 11/02/2022

Event Type  Injury  

Manufacturer Narrative

Device not returned to the manufacturer.

Event Description

The manufacturer received information alleging an issue related to a rep dreamstation avaps device.The manufacturer received information from the patient alleging that the patient has apnea, seizure, not breathing deeply.No medical intervention was required by the patient.The device has not been returned to the manufacturer.At this time, we are unable to confirm the alleged malfunction.A follow-up report will be submitted when the manufacturer's investigation is complete.

• Brand Name: REP DREAMSTATION AVAPS30
• 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: 18714831
• MDR Text Key: 335492984
• Report Number: 2518422-2024-07677
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: DSX1130S11F
• Device Catalogue Number: DSX1130S11F
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/02/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/07/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other