MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON MASK,NON-REBREATH W/SAFETY VENT,ELONGAT; MASK, OXYGEN, NON-REBREATHER

Catalog Number 1059

Device Problem Inflation Problem (1310)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/07/2017

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 was not returned at the time of this report.A picture of the defect was not provided.A device history record review shows that the device was assembled and inspected according to our specifications.Customer complaint cannot be confirmed based only on the information provided.In order to perform a proper investigation, and determine the source of the alleged defect reported, it is necessary to evaluate the sample involved on this complaint.If the device sample becomes available this investigation will be updated with the evaluation results.

Event Description

Customer complaint alleges that the reservoir bag did not inflate during use.A new unit was used.No report of patient harm.Patient condition was reported as "fine".

• Brand Name: HUDSON MASK,NON-REBREATH W/SAFETY VENT,ELONGAT
• Type of Device: MASK, OXYGEN, NON-REBREATHER
• 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: 6354340
• MDR Text Key: 68216273
• Report Number: 3004365956-2017-00076
• Device Sequence Number: 1
• Product Code: KGB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1059
• Device Lot Number: 74C1601549
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2016
• 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