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

Model Number 106MM

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 12/02/2014

Event Type  malfunction  

Event Description

It was reported the tubing from the oxygen mask did not fit securely to the mask while in use.The mask was discontinued and retrieved.An alternative product was 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: 4398085
• MDR Text Key: 5121731
• Report Number: 9680866-2015-00001
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 12/11/2014

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: 06/01/2019
• Device Model Number: 106MM
• Device Lot Number: 104798
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2014
• 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