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

Manufacturer Narrative

The investigation performed by quality department indicated that product was manufactured according to specifications and no discrepancies including non conformances or deviations were found.Though the quality issue could not be confirmed due to lack of defective samples, a previous investigation was created recently to investigate this type of complaint.This previous investigation is closed.Therefore, this complaint will be closed without further action.The investigation revealed the root cause to be a lack of chemical glue which resulted in the disconnection.All corrective actions have been implemented.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.

Manufacturer Narrative

Additional information: the nonconformance has been closed and therefore this complaint will be closed as well.Root causes identified were old machine not conditioned with alarm to detect and prevent double cycle in the process and inadequate inspection process for nebulizers.All corrective and preventive actions have been implemented.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).

• Brand Name: OPTI-MIST PLUS MASK KIT, NEBULIZER WITH AEROSO
• Type of Device: NEBULIZER (DIRECT PT INTERFACE)
• Manufacturer (Section D): UNOMEDICAL S.A. DE C.V.; av. industrial falcon 4; 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: 4768501
• MDR Text Key: 5948699
• Report Number: 9680866-2015-00030
• 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,foreign,health profe
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• 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?: No
• Initial Date Manufacturer Received: 04/28/2015
• Initial Date FDA Received: 05/12/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/13/2016; 01/13/2016
• 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