MAUDE Adverse Event Report: PARI RESPIRATORY EQUIPMENT, INC. - MIKE JUDGE VIOS; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number 310F83-LC+

Device Problem Sparking (2595)

Patient Problem Insufficient Information (4580)

Event Date 10/07/2020

Event Type  malfunction  

Manufacturer Narrative

This is an isolated incident at this time.After several calls with the patient and a discussion with the physical therapist, we have been unable to retrieve the device for evaluation.We attempted to have an electrician come to the house and inspect the device and the wall outlet, but the patient gave conflicting information as to the device's whereabouts, precluding such on-site inspection.Our conversations with the patient were challenging, as she was upset, seemed confused, and was difficult to understand.Patient refused to accept replacement product.Our investigation of production records and data did not identify anything that would contribute to such a malfunction, and we have not received any other similar reports for this product from this production period.Nevertheless, since we are unable to obtain adequate information from the patient or evaluate the product, we are submitting this form fda 3500a.

Event Description

Electrical event [device electrical finding].On (b)(6) 2020, a spontaneous report was received from a consumer regarding a (b)(6) year-old female patient's experience with vios (nebulizer).The patient was noted to blind and in a wheelchair.On (b)(6) 2020, the consumer stated that when her physical therapist plugged the compressor power cord into the wall outlet, they saw flames come out of the outlet.Neither patient nor therapist were injured according to the therapist.

• Brand Name: VIOS
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): PARI RESPIRATORY EQUIPMENT, INC. - MIKE JUDGE; 2412 pari way; midlothian VA 23112
• Manufacturer (Section G): TECNOLOGIAS MEDICAS INNOVADORAS S DE RL; calle 18 y herrera #84; matamoros, tamaulipas 87300 ; MX 87300
• Manufacturer Contact: mike judge ; vp operations and ra; 2412 pari way; midlothian, VA 23112 ; 8003278632
• MDR Report Key: 10805066
• MDR Text Key: 216937691
• Report Number: 3003767629-2020-00001
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 00744229310679
• UDI-Public: 00744229310679
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092918
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/06/2020

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: 310F83-LC+
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/07/2020
• Initial Date FDA Received: 11/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 96 YR