MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON MASK,NON-REBREATING W/O SFTY VENT,ELONG; MASK, OXYGEN, NON-REBREATHING

Catalog Number 41060

Device Problem Inflation Problem (1310)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer complaint alleges "whist using a high concentration oxygen mask (adult size) with an oxygen bottle, the nurse reported that the balloon did not inflate".Alleged malfunction reported as occurred during a patient use.It was reported there was no consequence for the patient.The patient condition was reported as "fine".

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was available for analysis.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

Customer complaint alleges "whist using a high concentration oxygen mask (adult size) with an oxygen bottle, the nurse reported that the balloon did not inflate".Alleged malfunction reported as occurred during a patient use.It was reported there was no consequence for the patient.The patient condition was reported as "fine".

• Brand Name: HUDSON MASK,NON-REBREATING W/O SFTY VENT,ELONG
• Type of Device: MASK, OXYGEN, NON-REBREATHING
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• 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: 7615713
• MDR Text Key: 111667652
• Report Number: 3004365956-2018-00205
• Device Sequence Number: 1
• Product Code: KGB
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 41060
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1