MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON HUMID VENT COMPACT S; FILTER, BACTERIAL, BREATHING CIRCUIT

Catalog Number 19401

Device Problem Partial Blockage (1065)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/18/2017

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: ersurgical 5000000.Qn#(b)(4).The actual device involved in this complaint was not returned, however a representative device sample was returned to the manufacturer.Evaluation of said device is still in progress at the time of this report.

Event Description

Customer complaint alleges the "alarm blocked the device and the patient was not ventilated." it was reported the nurse was at the bedside, and there were no clinical consequences for the patient.

Manufacturer Narrative

Concomitant medical products: ersurgical 5000000, qn#: 20019218.A device history record (dhr) review could not be performed as the lot number was unknown.The actual sample was not returned for evaluation; therefore, ten pieces of the same catalog number were taken from current production at the manufacturing facility to test the reported defect.A visual inspection was performed on all ten samples and no defects were observed.In addition, functional testing was performed and all samples passed the leak and drop test.In the current manufacturing procedure, 100% leak testing and drop test sampling are conducted at the assembly area; therefore, any defective products would be detected prior to release from the manufacturing facility.The complaint could not be confirmed as the actual sample was not returned.

Event Description

Customer complaint alleges the "alarm blocked the device and the patient was not ventilated." it was reported the nurse was at the bedside, and there were no clinical consequences for the patient.

• Brand Name: HUDSON HUMID VENT COMPACT S
• Type of Device: FILTER, BACTERIAL, BREATHING CIRCUIT
• Manufacturer (Section D): TELEFLEX MEDICAL; perak, west malaysia
• 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: 6308693
• MDR Text Key: 66768425
• Report Number: 8040412-2017-00040
• Device Sequence Number: 1
• Product Code: CAH
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 01/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 19401
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/03/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2017
• 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: DRAGER EVITA INFINITY V5OO AND/OR EVITA2 DURA, INT