MAUDE Adverse Event Report: UNOMEDICAL S.A. DE C.V. OXYGEN AND AEROSOL THERAPY; MASK, OXYGEN, NON-REBREATHING

Model Number 3104-E

Device Problem Infusion or Flow Problem (2964)

Patient Problem Low Oxygen Saturation (2477)

Event Date 06/10/2014

Event Type  Injury  

Event Description

It was reported that the oxygen tubing became disconnected from the bag attachment creating a loss of oxygen delivery to the patient.The patient was found with an oxygen saturation of 50% and unresponsive.Bi-level positive airway pressure was initiated and patient became more responsive after 10-20 minutes.

Manufacturer Narrative

Based on the available information this event is deemed a serious injury.An initial quality evaluation was performed on (b)(4) 2014.Additional information was requested on (b)(4) 2014 and the following information was provided on (b)(4) 2014, "i'm sorry but we cannot provide detailed identifiers such as end user height and weight due to our (b)(6) privacy legislation.I also don't know whether product was replaced; all we know is that the customer inspected stock at several lots where the tape was not well applied." additional information was also received on (b)(4) 2014 which stated, "at this time i don't have more information, neither reports in regards to the "several lots" that customer mentions.However, customer states that they "found a couple of samples from several lots where the tape was not well applied." it is not an issue related to the reported disconnection of tube from mask connector.I have explained customer that the tape has the function to hold or glue the bag to mask connector.This tape covers the surface around the connection of the bag and mask connector.I will wait for the samples to evaluate and determine if it is something wrong with the tape." the complaint sample has been requested for evaluation.This complaint is being evaluated.This is the first complaint of this type received for this product.No previous investigation exists for this issue for this product.Based on this review unable to determine if product meets specification.An investigation is required to determine if any further actions are required.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.

• Brand Name: OXYGEN AND AEROSOL THERAPY
• Type of Device: MASK, OXYGEN, NON-REBREATHING
• Manufacturer (Section D): UNOMEDICAL S.A. DE C.V.; av. industrial falcon secc. 4; lote 7, parque ind. del norte; reynosa 8873 6; MX 88736
• Manufacturer Contact: matthew walenciak, assoc dir ; 211 american ave; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 3971237
• MDR Text Key: 4626824
• Report Number: 9680866-2014-00016
• Device Sequence Number: 1
• Product Code: BYG
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2019
• Device Model Number: 3104-E
• Device Catalogue Number: 3104-E
• Device Lot Number: 102787
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2014
• 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
• Patient Outcome(s): Required Intervention