MAUDE Adverse Event Report: UNOMEDICAL S.A. DE C.V. OPTI-MIST CLEAR NEBULIZER, 7 FT. (2.1M) OXYGEN; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number 776-E

Device Problems Improper Flow or Infusion (2954); Infusion or Flow Problem (2964)

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

Event Type  malfunction  

Event Description

It was reported the nebulizer did not produce the expected flow when set a flow rate of 6 liters per minute (lpm) flow rate.The nebulizer flow rate was reportedly increased to 10 lpm, in order to obtain the desired amount of nebulization.No pt consequences were reported as a result of this event.

Manufacturer Narrative

Based on the available info, this event is deemed a reportable malfunction.There were no reports of the pt being harmed as a result of this malfunction.Additional pt/event details have been requested.Should additional info become available a follow-up report will be submitted.

• Brand Name: OPTI-MIST CLEAR NEBULIZER, 7 FT. (2.1M) OXYGEN
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• 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 asso dir ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4701889
• MDR Text Key: 5650744
• Report Number: 9680866-2015-00029
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K791536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 776-E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/30/2015
• Initial Date FDA Received: 04/16/2015
• 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