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

Model Number FRX1130S14

Device Problems Contamination (1120); Corroded (1131)

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

Event Date 12/01/2023

Event Type  malfunction  

Event Description

A device was returned to a third-party 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 evaluation, corrosion was found on the power connector and the unit can't be power on in order to be able to collect the error code or log/machine hours/error code numbers/software version.In addition, corrosion was found on metallic surfaces and dust or dirt contamination was found inside the device.There is no allegation of serious or permanent harm or injury.The manufacturer is submitting a final report at this time.If patient information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.The device was scrapped.

Manufacturer Narrative

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

Manufacturer Narrative

The manufacturer received information in relation to a dreamstation avaps30 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.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
• 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 ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 18324653
• MDR Text Key: 330483261
• Report Number: 2518422-2023-35461
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• 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: 12/01/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/24/2018
• 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