MAUDE Adverse Event Report: RESPIRONICS, INC. INNOSPIRE GO; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number 1126593

Device Problem Corroded (1131)

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

Event Date 12/08/2023

Event Type  malfunction  

Manufacturer Narrative

H3 other text: device not returned to manufacturer.

Event Description

The manufacturer received information alleging a innospire go device has oxidized charging ports.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The manufacturer received information alleging a innospire go device has oxidized charging ports.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.Analysis of past events has not indicated an adverse event has occurred due to corrosion.Review of the risk file indicates the potential for a serious adverse event occurring as a result of this incident is unlikely.Additionally, the risk file indicates that corrosion will not substantially affect the performance of the device.This complaint is considered not reportable.

• Brand Name: INNOSPIRE GO
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• 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: 18349841
• MDR Text Key: 330753687
• Report Number: 2518422-2023-36281
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 00383730000534
• UDI-Public: 00383730000534
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K170853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1126593
• Device Catalogue Number: 1126593
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/02/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1