MAUDE Adverse Event Report: UNOMEDICAL S.A. DE C.V. OXYGEN AND AEROSOL THERAPY; VENTILATOR, EMERGENCY, MANUAL, 73BTM

Model Number 778500

Device Problems Delivery System Failure (2905); Improper Flow or Infusion (2954)

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

Event Date 10/03/2014

Event Type  malfunction  

Event Description

It was reported exhalation valve failure.There was inability to provide breaths during cpr.When compressing ambubag, air came out of exhalation valve and did not go to pt.The pt status is unk.

Manufacturer Narrative

Based on the available info, this event is deemed to be a reportable malfunction.Additional info has been requested, however no additional info has been provided to date.Should additional info become available, a follow-up report will be submitted.Reported to the fda on (b)(6) 2014.Fda registration number reporting site: (b)(4).Mfg site: (b)(4).

• Brand Name: OXYGEN AND AEROSOL THERAPY
• Type of Device: VENTILATOR, EMERGENCY, MANUAL, 73BTM
• 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, dir ; interim associate med safety & compliance; 211 american ave; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4208901
• MDR Text Key: 4967261
• Report Number: 9680866-2014-00038
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K873286
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2012
• Device Model Number: 778500
• Device Catalogue Number: 778500
• Device Lot Number: 09-24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2009
• 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