MAUDE Adverse Event Report: UNOMEDICAL SA DE CV NON-REBREATHER OXYGEN MASK, ADULT; MASK, OXYGEN, NON-REBREATHING

Model Number 108MM

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Expiration date: 08/2019.Based on the available information, this event is deemed to be a reportable malfunction.No patient harm was reported.Additional details have been requested but not provided to date.Should additional information become available, a follow-up report will be submitted.(b)(4).Note: a total of (b)(4) cases are associated with this complaint.A separate fda form 3500a has been completed for that case.

Event Description

Complaint received from a distributor reporting that "the tube break off from the mask.This occurs the oxygen de-saturation for the patient." the issue was noted at the fixation between mask and tube.A photo was received depicting the reported product complaint.

Manufacturer Narrative

A preliminary evaluation of the reported cases were reviewed collectively due to similar failure modes reported for tubing disconnecting from mask.These complaints included a review of complaints reported between october 27, 2014 to october 27, 2016 (2 year period) for this failure.Additionally, the last product monitoring reviews (pmrs) were also reviewed and no trends were identified.This issue will be monitored through the post market product monitoring review process.No additional patient/event details have been provided to date.Should additional information become available, a follow-up report will be submitted.Reported to the fda on december 27, 2016.

• Brand Name: NON-REBREATHER OXYGEN MASK, ADULT
• Type of Device: MASK, OXYGEN, NON-REBREATHING
• Manufacturer (Section D): UNOMEDICAL SA DE CV; av. industrial falcon lote 7; parque ind del norte; reynosa, tamaulipas 88736 ; MX 88736
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5783846
• MDR Text Key: 49235210
• Report Number: 9680866-2016-00079
• Device Sequence Number: 1
• Product Code: KGB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 108MM
• Device Lot Number: 105987
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1