MAUDE Adverse Event Report: RESPIRONICS, INC. REP DREAMSTATION AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number RJPX500S16F

Device Problems Degraded (1153); Smoking (1585)

Patient Problems Asthma (1726); Unspecified Eye / Vision Problem (4471)

Event Date 03/18/2024

Event Type  Injury  

Event Description

The manufacturer was contacted in reference to the voluntary field safety notice/recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received information alleging an issue related to a rep dreamstation auto cpap device's sound abatement foam.The patient has alleged eyes hurt, asthma, motor inside might have been burned out, causing harm to his/her body, and smoking.No medical intervention was specified by the patient.The device has not yet been returned to the manufacturer for evaluation.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

H3 other text : device not returned to manufacturer.

• Brand Name: REP DREAMSTATION AUTO CPAP
• 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: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18959918
• MDR Text Key: 338368654
• Report Number: 2518422-2024-14868
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K091319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: RJPX500S16F
• Device Catalogue Number: RJPX500S16F
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/19/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other