MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON UNIVERSAL CONCHA COLUMN; HUMIDIFIER, RESPIRATORY GAS, (

Catalog Number 382-10

Device Problem False Alarm (1013)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/11/2018

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 or a picture of the alleged defect was not provided.According to the batch number 74l1700775 provided by the customer the finished good is (b)(4).The device history record (dhr) of the product (b)(4) batch number 74l1700775 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.Dhr shows that the product was assembled and inspected according to our specifications.Customer complaint cannot be confirmed due the lack of device sample to perform a proper investigation.Root cause is unknown.If the device sample becomes available this report will be updated.Teleflex will continue to monitor customer feedback for complaints of this nature.

Event Description

Customer alleges the device is signaling the low water alarm when the water is not low.Alleged issue reported as occurred during a patient use.It was reported there was no patient injury or consequence.

• Brand Name: HUDSON UNIVERSAL CONCHA COLUMN
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (
• 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: 7634067
• MDR Text Key: 112237665
• Report Number: 3004365956-2018-00209
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141940
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/12/2018

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
• Device Operator: No Information
• Device Catalogue Number: 382-10
• Device Lot Number: 74L1700775
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/12/2018
• Initial Date FDA Received: 06/25/2018
• 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