MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON AQUAPAK 301 SW,340 ML,INTL; RESPIRATORY GAS HUMIDIFIER

Catalog Number 400301

Device Problem Failure to Deliver (2338)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/08/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device involved in this complaint has not been received by the manufacturer for evaluation at the time of this report.Review of manufacturing event log shows no issues that may have contributed to any quality issues reported.All process parameters were within specification.The sample is needed for a proper and thorough investigation.Complaint not confirmed.Root cause cannot be determined.If the sample becomes available, this report will be updated with the evaluation results.

Event Description

Customer complaint alleges "when using the aquapak, there were no bubbles when the oxygen passes." there was no report of patient impact or consequence.

• Brand Name: HUDSON AQUAPAK 301 SW,340 ML,INTL
• Type of Device: RESPIRATORY GAS HUMIDIFIER
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 900 west university dr.; arlington heights IL 60004
• Manufacturer Contact: linda woodall ; 3015 carrington mill blvd; morrisville 27560 ; 9196942566
• MDR Report Key: 8264760
• MDR Text Key: 134323928
• Report Number: 1417411-2019-00010
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/14/2021
• Device Catalogue Number: 400301
• Device Lot Number: 474177
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2017
• 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