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

Model Number 128MMUK

Device Problem Connection Problem (2900)

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

Event Date 09/03/2014

Event Type  malfunction  

Event Description

It was reported that the oxygen tubing and mask interface do not stay connected.This was reported to have occurred on three separate occasions on the same patient.The patient required oxygen via face mask to maintain oxygen saturations of greater than 94%.Oxygen tubing disconnected from the face mask.Physician attached to oxygen tubing to the face mask and checked patient's oxygen saturations, which were coming up from the low 80s to settle at 96% a few minutes after oxygen was reapplied.

Manufacturer Narrative

Based on the available info, this event is deemed to be a reportable malfunction.It was further reported of two (2) similar incidents had occurred in the 2 days previously.Oxygen tubing and face mask were immediately reconnected and staff nurse on ward was informed.Staff nurse reported she was already aware of the problem and that the patient was pulling at the oxygen tubing however this was not witnessed by the physician.No additional info has been provided to date.Should additional info become available, a follow-up report will be submitted.(b)(4).Note: there are two cases associated with this product, one for the mask and one for the tubing; this case is to address the tubing.An additional fda form 3500a has been generated to address the mask.

• Brand Name: OXYGEN & AEROSOL THERAPY
• Type of Device: MASK, OXYGEN, NON-REBREATING, 73KGB
• 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, direc. ; 211 american ave; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4239663
• MDR Text Key: 4987096
• Report Number: 9680866-2014-00037
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 128MMUK
• Device Catalogue Number: 128MMUK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2014
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention