MAUDE Adverse Event Report: UNOMEDICAL S.A. DE C.V. ADULT HIGH CONCENTRATION NON-REBREATHER OXYGEN; MASK, OXYGEN, NON-REBREATHING

Model Number 106MM

Device Problems Detachment Of Device Component (1104); Fitting Problem (2183)

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

Event Type  malfunction  

Event Description

It was reported the oxygen tubing was "poorly fitted" and detached from the mask during use.The mask remained in use.No patient harm was reported.

Manufacturer Narrative

Based on the available info, this event is deemed a reportable malfunction.There was no report of the patient being harmed as a result of this malfunction.An investigation into the reported issue is currently underway.Additional patient and event details have been requested.Should additional info become available, a f/u report will be submitted.

• Brand Name: ADULT HIGH CONCENTRATION NON-REBREATHER OXYGEN
• Type of Device: MASK, OXYGEN, NON-REBREATHING
• Manufacturer (Section D): UNOMEDICAL S.A. DE C.V.; av. industrial falcon; lote 7, parque ind. del norte; reynosa, tamaulipas. 8873 6; MX 88736
• Manufacturer Contact: matthew walenciak, dir ; 211 american ave; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4398084
• MDR Text Key: 5368258
• Report Number: 9680866-2015-00004
• Device Sequence Number: 1
• Product Code: KGB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2019
• Device Model Number: 106MM
• Device Lot Number: 104106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• 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