MAUDE Adverse Event Report: UNOMEDICAL S.A. DE C.V. OPTI-MIST PLUS MASK KIT, NEBULIZER WITH AEROSO; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number 3773MM

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Patient Involvement (2645)

Event Date 04/28/2015

Event Type  malfunction  

Event Description

It was reported that nebulizer didn't operate when powered on during pretesting.The nebulizer allegedly "made noise" but did not produce an aerosol steam.As a result, the device was not used on the pt.

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.Should add'l info become available, a f/u report will be submitted.

• Brand Name: OPTI-MIST PLUS MASK KIT, NEBULIZER WITH AEROSO
• 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 8873 6; MX 88736
• Manufacturer Contact: matthew walenciak, interim assoc ; 211 american ave; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4768474
• MDR Text Key: 20075108
• Report Number: 9680866-2015-00034
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K791536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/28/2015

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 Expiration Date: 07/01/2019
• Device Model Number: 3773MM
• Device Lot Number: 105415
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2015
• Initial Date FDA Received: 05/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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