MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION ST25, EU; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number EUX1025S15

Device Problems Degraded (1153); Power Problem (3010)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

H3 other text : analysis by third-party.

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.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.A device was returned to the manufacturer for evaluation 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, the third-party service center visually inspected the device and has no visualization of foam particles.In addition to above findings, the power connector of the unit is corroded, the unit cannot be power on and the device was verified that the power source was not connected.The device was routed to scrap.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.

Manufacturer Narrative

This complaint has been previously submitted as part of recall with recall number z 1973-2021, this incident has been deemed reportable due to the corrosion found on the power connector only and not part of recall.The correct event description should be- the manufacturer received information regarding a devastation st25.The device was returned to a third party service center.During visual inspection of the device, corrosion was found on the power connector.This report is being submitted for the corrosion found on the power connector during service.There was no allegation of serious or permanent harm or injury.No medical intervention was required for the patient.The third party service center visually inspected the device.During evaluation, corrosion was found on the power connector.In addition, corrosion on metallic surfaces and dust/dirt were also observed on the device.This incident has been deemed reportable due to the corrosion found on the power connector.The device was scrapped.Section h: remedial action init (rfb) and recall (z) number (rfb) has been corrected/ updated in this report.

• Brand Name: DREAMSTATION ST25, EU
• 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: 18116531
• MDR Text Key: 327864662
• Report Number: 2518422-2023-29917
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K102465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: EUX1025S15
• Device Catalogue Number: EUX1025S15
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/22/2023
• Initial Date FDA Received: 11/10/2023
• Supplement Dates Manufacturer Received: 10/22/2023
• Supplement Dates FDA Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/06/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1973-2021
• Patient Sequence Number: 1