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

Model Number 106-E

Device Problem Connection Problem (2900)

Patient Problem Respiratory Distress (2045)

Event Date 09/17/2014

Event Type  malfunction  

Event Description

It was reported the oxygen supply hose came off of the mask when in use.

Manufacturer Narrative

Based on the available information, this event is deemed to be a reportable malfunction.The patient required oxygen therapy (o2 therapy).The device was removed/discontinued.There was no reported harm to the patient.Further information stated, "the complaints came in from various units throughout the city.These were the lots that were able to identify from the stock that they were using on each ambulance." no additional patient/event details have been provided to date.Should additional information become available, a follow up report will be submitted.There are six cases associated with this product; therefore, five separate fda form 3500a have been generated to address the other cases.

• Brand Name: OXYGEN & 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, tams. 8873 6; MX 88736
• Manufacturer Contact: matthew walenciak, int.assoc.dire ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4173030
• MDR Text Key: 5090306
• Report Number: 9680866-2014-00028
• Device Sequence Number: 1
• Product Code: KGB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 09/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2019
• Device Model Number: 106-E
• Device Catalogue Number: 106-E
• Device Lot Number: 103122
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/17/2014
• 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