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

Model Number FRX1130S14

Device Problem Corroded (1131)

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

Event Date 12/05/2023

Event Type  malfunction  

Event Description

The manufacturer received information regarding a dreamstation avaps30 aam.The device was returned to a third-party service center for evaluation.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 surface 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.The manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.

Manufacturer Narrative

H3 other text : device evaluated by third party service center.

Manufacturer Narrative

The manufacturer received information in relation to a dreamstation avaps unit.The device was returned to a third party service center.During visual inspection of the device, it was determined the power connector of the unit was corroded and the unit didn't power on.Corrosion on metallic surfaces and dust/dirt contamination were also found during device evaluation.Device was scrapped at customer's request.Analysis of past events has not indicated an adverse event has occurred due to corrosion.Review of the risk file indicates the potential for a serious adverse event occurring as a result of this incident is unlikely.Additionally, the risk file indicates that corrosion will not substantially affect the performance of the device.This complaint is considered not reportable.

• Brand Name: DREAMSTATION AVAPS30 AAM
• 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: 18503977
• MDR Text Key: 332974091
• Report Number: 2518422-2024-02230
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K102465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: FRX1130S14
• Device Catalogue Number: FRX1130S14
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/30/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1