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

Model Number 86-775-E

Device Problems Device Operates Differently Than Expected (2913); Infusion or Flow Problem (2964)

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

Event Date 11/30/2015

Event Type  malfunction  

Manufacturer Narrative

Based on the available information, this event is deemed a reportable malfunction.No further information was available at the time of the report.No lot number or complaint sample was available for evaluation.A detailed investigation or batch review could not be conducted.Therefore, this evaluation will be closed and will be monitored through our post market product monitoring review process.Should additional information become available, a follow-up report will be submitted.Note: this fda 3500a form has been generated to account for the second defective device.(b)(4).

Event Description

It was reported that during use on a patient, the nebulizer "would not mist".The device was removed and replaced with another device that had the same issue.A competitors device was used without any further issues.

• Brand Name: OPTI-MIST CLEAR NEBULIZER,7FT. (2.1M) OXYGEN
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): UNOMEDICAL S. A. DE C.V; av. industrial falcon, lote 7,; parque ind. del norte; reynosa, tamaulipas 88736 ; MX 88736
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5325369
• MDR Text Key: 34301755
• Report Number: 9680866-2015-00116
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K791536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 86-775-E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2015
• 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: Initial
• Patient Sequence Number: 1