MAUDE Adverse Event Report: HUDSON 22MM HTD NIV CIRC KIT W/FILTER; HUMIDIFIER NEBULIZER KIT

Model Number	IPN913839
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "when they use the circuits with this lot number, the vent throws an alarm until the circuit is changed to one not from this lot number.Pt care is not affected except by the alarm noise.No clinical deterioration".Patient condition reported as "fine".

• Brand Name: HUDSON 22MM HTD NIV CIRC KIT W/FILTER
• Common Device Name: HUMIDIFIER NEBULIZER KIT
• MDR Report Key: 12347202
• Report Number: 3003898360-2021-00692
• Device Sequence Number: 12085326
• Product Code: OGG
• UDI-Device Identifier: 14026704660473
• UDI-Public: 14026704660473
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/26/2021

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: No Information
• Device Expiration Date: 05/07/2025
• Device Model Number: IPN913839
• Device Catalogue Number: 870-98KITF
• Device Lot Number: 74F2000191
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2021
• Initial Report FDA Received Date: 08/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VENTILATOR