MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON 780-18 CIRCUIT W/ COLUMN; HUMIDIFIER,NEBULIZER KIT

Catalog Number 780-18KIT

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/08/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual, dimensional and functional inspection of the device involved in the complaint could not be conducted since the device was not returned at the time of this report.A device history record review could not be conducted since the lot number provided (454387087) is not a valid lot number.Customer complaint cannot be confirmed based only on the information provided.In order to perform a proper investigation and determine the source of the alleged defect reported, it is necessary to evaluate the sample involved in this complaint.If the device sample becomes available at a later date this report will be updated.

Event Description

Customer complaint alleges an issue with the circuit breaking at the temp probe.Alleged defect reported as occurring during use.It was reported there was no injury or consequence to the patient.Patient's condition reported as "fine".

• Brand Name: HUDSON 780-18 CIRCUIT W/ COLUMN
• Type of Device: HUMIDIFIER,NEBULIZER KIT
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: linda woodall ; 3015 carrington mill blvd; morrisville 27560 ; 9196942566
• MDR Report Key: 6664119
• MDR Text Key: 78297303
• Report Number: 3004365956-2017-00254
• Device Sequence Number: 1
• Product Code: OGG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 780-18KIT
• Device Lot Number: 454387087
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 6 DA