MAUDE Adverse Event Report: RESPIRONICS, INC. \; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	FRX500S14
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A device was returned to a third-party repair center for service.The device was not in patient use.During the service evaluation of the device, the third-party repair center visually inspected the device and found corrosion on the power supply connectors.The device was not able to power up.There was no report of patient or user harm or injury.The manufacturer is submitting a final report at this time.
Additional Manufacturer Narrative
H3 other text : sent to a third-party service center.
Additional Manufacturer Narrative
A device was returned to a third-party repair center for service.The device was not in patient use.During the service evaluation of the device, the third-party repair center visually inspected the device and found corrosion on the power supply connectors.The device was not able to power up.There was no report of patient or user harm or injury.The manufacturer is submitting a final report at this time.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.
Additional Manufacturer Narrative
The udi in section d4 was previously reported in the incorrect format.The udi information has been updated to the correct format.

• Brand Name: \
• Common Device Name: 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: melissa rosko ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18013845
• Report Number: 2518422-2023-27910
• Device Sequence Number: 20717272
• Product Code: BZD
• UDI-Device Identifier: 00606959043060
• UDI-Public: (01)00606959043060
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/24/2024

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
• Operator of Device: Lay User/Patient
• Device Model Number: FRX500S14
• Device Catalogue Number: FRX500S14
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2023
• Supplement Date Received by Manufacturer: 09/26/2023; 09/26/2023
• Initial Report FDA Received Date: 10/26/2023
• Supplement Report FDA Received Date: 02/13/2024; 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/21/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown