MAUDE Adverse Event Report: UNOMEDICAL S.A. DE C.V. OXYGEN & AEROSOL THERAPY; MASK, OXYGEN, 73BYG

Model Number 100MM

Device Problem Decoupling (1145)

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

Event Date 06/19/2014

Event Type  malfunction  

Event Description

It was reported that a pt received oxygen by mask greater than 15 liters flow on the mask.The connector between the mask and the tube from face piece disconnected.The flow of oxygen was disconnected for a short time.

Manufacturer Narrative

Based on the available info, this event is deemed a reportable malfunction.This device was used on a pt, however, there was no harm to the pt reported.An inial investigation was conducted on 07/08/2014.The investigation performed by the quality dept based on the examination of batch records and current production samples indicated that product was manufactured according to specifications.As the aerosol masks/connectors are used for products of other customers and other products, the investigation was extended to include the products.The investigation revealed that there were no add'l complaints nor adverse events reported for the other products sold in addition to product 100mm over the 12 months period.The recommendation is to keep tracking the complaints trends, to confirm if the design and the process are using the best available technology such as comparing the aerosol mask with similar devices, and to assess the feasibility of improvements to increase retention of mask connector with other manufacturer medical devices.Note: issue occurred on (3) separate cases.A separate 3500 a form has been completed for the other (2) cases.Pt identifiers: (b)(6).No add'l pt/event details have been provided to date.Should add'l info become available, a f/u report will be submitted.

• Brand Name: OXYGEN & AEROSOL THERAPY
• Type of Device: MASK, OXYGEN, 73BYG
• Manufacturer (Section D): UNOMEDICAL S.A. DE C.V.; av. industrial falcon; 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: 4023862
• MDR Text Key: 4722677
• Report Number: 9680866-2014-00019
• Device Sequence Number: 1
• Product Code: BYG
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100MM
• Device Catalogue Number: 100MM
• Device Lot Number: CNO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/04/2014
• 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