MAUDE Adverse Event Report: THAYER MEDICAL CORPORATION MINISPACER; VENTILATOR ADAPTER FOR METERED DOSE INHALERS

Model Number 1021

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 10/22/2018

Event Type  malfunction  

Manufacturer Narrative

Thayer has attempted but been unable to get any additional information about this incident from (b)(6).On (b)(6) 2018, (b)(6), informed thayer that (b)(6) had determined thayer's minispacer was not responsible for patient adverse event.She also did not respond to further inquiries by thayer on patient status.

Event Description

(b)(6) employee, (b)(6), reports to thayer that one of their nurses set up a non-invasive ventilator circuit for a patient who was to be released from the hospital and return home for a follow-up oxygen breathing treatment via trachea.Equipment assembled by the nurse included an air compressor, an oxygen concentrator with connected tubing and a thayer minispacer device for in-line mdi treatment.The nurse connected the out-going oxygen tubing to the in-going actuator port of the minispacer with intent to introduce concentrated oxygen into the patients airway.This is not the intended use of the minispacer.(b)(6) also stated that once the patient was home again and connected to the circuit, the nurse was certain the patient was receiving oxygen as intended up to and including a flow rate of 4 l/min.Once the nurse increased flow to 6 l/min, there was some (unstated) indication that the flow was too high and the patient was likely not receiving a full 6 l/min of concentrated oxygen.(b)(6) informed that the paramedics were called when there appeared to be a problem with the patient's trach.When the paramedics arrived, one of the emt's observed the "oxygen portal" into the vent line and stated that the adapter was not to be used at a flow rate as high as 6 l/min as it cannot handle it.It appears that both the nurse and the emt thought the mlnispacer was an in-line oxygen adapter.Regardless of their packaging differences, apparently the actual devices look visually similar.(b)(6) explained that the patient was taken lo the hospital because of the need for a repair to his trach, not due to in appropriate oxygenation.Thayer has been advised that the patient is currently undergoing surgery to repair the trach and there is no further update at present (12:30 pm, (b)(6) 2018).

• Brand Name: MINISPACER
• Type of Device: VENTILATOR ADAPTER FOR METERED DOSE INHALERS
• Manufacturer (Section D): THAYER MEDICAL CORPORATION; 4575 s palo verde rd.; suite 337; tucson AZ 85714
• Manufacturer (Section G): THAYER MEDICAL CORPORATION; 4575 s palo verde rd.; suite 337; tucson AZ 85714
• Manufacturer Contact: jennifer johnson ; 4575 s palo verde rd.; suite 337; tucson 85714 ; 5207905393
• MDR Report Key: 8438965
• MDR Text Key: 139715483
• Report Number: 2026894-2018-00001
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K901739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1021
• Device Catalogue Number: 2063
• Device Lot Number: 070345
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/22/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/31/2007
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 53 YR