MAUDE Adverse Event Report: UNOMEDICAL SA DE CV 3-IN-1 MASK ADULT; MASK, OXYGEN, NON-REBREATHING

Model Number 1635-10

Device Problems Defective Device (2588); Connection Problem (2900)

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

Event Date 10/29/2012

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).Evaluation conclusions are reflected in the codes.

Event Description

Complainant reports "the connector bush that sits in the end of the mask, comes out when the oxygen nipple is removed in order to use as a aerosol mask nebuliser, then does not fit and medication cannot be given.Customer stats it looks like it is not glued in properly.Also the ambient temperature in the area that is ambulance operates is approximately 8 degrees celsius.".

• Brand Name: 3-IN-1 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 ; 211 american ave; greensboro, NC 27409 ; 3362973009
• MDR Report Key: 5208109
• MDR Text Key: 30640937
• Report Number: 9680866-2015-31248
• Device Sequence Number: 1
• Product Code: KGB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1635-10
• Device Lot Number: 11-36
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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