MAUDE Adverse Event Report: OK BIOTECH CO., LTD. PRODIGY MINI-MIST PORTABLE NEBULIZER

Model Number 32500A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Asthma (1726)

Event Date 10/09/2016

Event Type  malfunction  

Manufacturer Narrative

The suspected device were check and found the mesh on the medicine cup was recessed, which make the device cannot nebulise or not enough mist output.This problem might because the patient inappropriate use of the device or failure to appropriately maintain the device.

Event Description

End user reported that his prodigy nebulizer was not misting properly and medical attention was sought in (b)(6) 2016 after he suffered an asthma attack.He visited the er and received one albuterol treatment.No further details were provided.

• Brand Name: PRODIGY MINI-MIST PORTABLE NEBULIZER
• Type of Device: MINI-MIST PORTABLE NEBULIZER
• Manufacturer (Section D): OK BIOTECH CO., LTD.; no. 91, sec. 2,; gongdao 5th road; hsinchu, taiwan 30070 ; TW 30070
• Manufacturer (Section G): OK BIOTECH CO., LTD.; no. 91, sec. 2,; gongdao 5th road; hsinchu, taiwan 30070 ; TW 30070
• Manufacturer Contact: joanna wang ; no. 91, sec. 2; gongdao 5th road; hsinchu, taiwan 30070 ; TW 30070 ; 3 5160258
• MDR Report Key: 6123722
• MDR Text Key: 61027152
• Report Number: 3005862821-2016-00099
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090307
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 10/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 32500A
• Device Catalogue Number: 32500A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2016
• Date Manufacturer Received: 10/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: LISINOPRIL; MELOXICAM; METFORMIN; SINGULAIR
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Weight: 115