MAUDE Adverse Event Report: RESPIRONICS, INC. CUSTOM INNOSPIRE MINI MED4HOME; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number 1125473

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 03/28/2023

Event Type  malfunction  

Event Description

The manufacturer received information that the customer's nebulizer is not working.The customer stated that the switch was bad and that he must hold the switch down and forward for the compressor to function.There is no allegation of serious or permanent harm or injury.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

H3 other text : device not returned to manufacturer.

• Brand Name: CUSTOM INNOSPIRE MINI MED4HOME
• 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: 18028495
• MDR Text Key: 326799295
• Report Number: 2518422-2023-28083
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 00383730003979
• UDI-Public: 00383730003979
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060404
• 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
• Report Date: 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1125473
• Device Catalogue Number: 1125473
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/28/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/06/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1