MAUDE Adverse Event Report: RESPIRONICS, INC. INNOSPIRE GO; PORTABLE MESH NEBULIZER

Model Number 1126591

Device Problem Failure to Power Up (1476)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/21/2023

Event Type  malfunction  

Event Description

The manufacturer was contacted in reference to an innospire go nebulizer with information alleging the device would not turn on.There was no harm or injury reported.No medical intervention was required by the patient.A nebulizer device was returned to the manufacturer for evaluation.During the evaluation of the device at the manufacturer's service center, the service technician confirmed the device had no power and would not turn on.1.Pil visually inspected the innospire go for obvious defects finding corrosion on all connection pins.No physical damage to the device or power supply, normal wear, and tear.The charger came in with the device.2.The device has mild environmental contamination built up throughout the medicine delivery port, air inlet, and mouthpiece.The pil found corrosion on both sets of the device's 2-prong charging pins for the charger to mouthpiece.Pil applied ac power though power supply sent.Device will not charge or power on.3.Pil tested the power supply/charger that came in with the device for voltage and resistance, reading 0v and opened reading for power supply/charger.The device appears to have possible ingress issues showing corrosion on all pins.Pil will attempt to scrape some corrosion off, attempt to charge, then try to power on.4.The device with its¿ power supply sent in doesn¿t work.Pil then tried a ¿known-good¿ device and that charger in place of with power supply, handset, or mouthpiece.The handset doesn¿t charge with either charger.The mouthpiece does work with pils known-good handset and charger but no other configuration.Mouthpiece appears to distribute medicine as intended no other sub assemble operates.Additional information: no additional findings.Summary: pil confirms "no power will not turn on".Pil verified that corrosion, liquid ingress, and power supply fuse opening caused the no power/charging issue.No other findings besides normal contamination wear and tear.

• Brand Name: INNOSPIRE GO
• Type of Device: PORTABLE MESH NEBULIZER
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18179605
• MDR Text Key: 328621996
• Report Number: 2518422-2023-31201
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 00383730002446
• UDI-Public: 00383730002446
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

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: Lay User/Patient
• Device Model Number: 1126591
• Device Catalogue Number: 1126591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2023
• Initial Date Manufacturer Received: 10/09/2023
• Initial Date FDA Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1