MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON BREATHING CIRC,ANES,ADULT,2.4M (96"); CIRCUIT, BREATHING

Catalog Number 351600

Device Problem Pressure Problem (3012)

Patient Problem Insufficient Information (4580)

Event Date 06/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This report is not late.This is a re-submission per fda request.Fda has reported there is an inability to change mfr report numbers in their system; therefore, this report will be re-submitted and will contain all information that was originally reported on both the initial and follow-up reports submitted previously.Initial report submitted on 07/01/2016 under mfr report #8040412-2016-00129.Follow up #1 report submitted on 08/12/2016 under mfr report #3004365956-2016-00316.Customer provided additional information regarding the product code indicating that it had changed; therefore, the mfr report number changed as well.Investigation information: a device history record (dhr) review could not be performed as the lot number provided by the customer was not a valid lot number.The sample was not returned for evaluation; therefore, the complaint could not be confirmed.If the sample is returned, a follow-up report will be submitted with investigation results.

Event Description

It was reported that "problems encountered with circuit: circuit too compliant - expands with each tidal volume.High paco2 noted, because fraction of tidal volume lost in circuit.Necessitates higher minute volume (frequency) to compensate.Especially problematic in high airway pressure.Crcuit moves with each tidal volume.".

• Brand Name: HUDSON BREATHING CIRC,ANES,ADULT,2.4M (96")
• Type of Device: CIRCUIT, BREATHING
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 5873017
• MDR Text Key: 230058396
• Report Number: 3004365956-2016-00316
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: SF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/14/2016

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 Catalogue Number: 351600
• Device Lot Number: PR020039896
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/14/2016
• Initial Date FDA Received: 08/12/2016
• 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