MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON HUMID-FLO HME; CONDENSER, HEAT AND MOISTURE

Catalog Number 19912

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Medwatch#: (b)(4).The investigation into this complaint is in progress at the time of this report.

Event Description

Customer complaint alleges that device was creating a leak on the ventilator.No report of patient harm or injury.

Manufacturer Narrative

(b)(4).The actual complaint sample was not returned for evaluation; therefore, ten pieces of the same catalog number in current production at the manufacturing facility were taken to test the reported defect.No defects were found on the samples.Leak testing was also conducted and all samples passed the test.In the current manufacturing procedure, 100% leak testing is conducted at the assembly area; therefore, any defects would be detected prior to release from the manufacturing facility.The reported complaint could not be confirmed as the actual sample was not returned for evaluation.If the sample is returned, a follow-up report will be submitted with investigation results.

Event Description

Customer complaint alleges that device was creating a leak on the ventilator.No report of patient harm or injury.

• Brand Name: HUDSON HUMID-FLO HME
• Type of Device: CONDENSER, HEAT AND MOISTURE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; po box 28, kamunting industrial estate; perak, west malaysia 34600 ; MY 34600
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6348983
• MDR Text Key: 67950518
• Report Number: 8040412-2017-00042
• Device Sequence Number: 1
• Product Code: BYD
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/31/2017

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: 19912
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/31/2017
• Initial Date FDA Received: 02/22/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/22/2017
• 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
• Treatment: VENTILATOR
• Patient Age: 72 YR