MAUDE Adverse Event Report: TELEFLEX INCORPORATED HUDSON RCI; NEBULIZER (DIRECT PATIENT INTERFACE)

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Low Oxygen Saturation (2477)

Event Date 06/01/2022

Event Type  malfunction  

Event Description

Hudson rci nebulizer became detached internally from the flow meter, which was not obviously visible.Patient began to desaturate, and equipment was temporarily fixed and replaced.

• Brand Name: HUDSON RCI
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 14914163
• MDR Text Key: 295231180
• Report Number: 14914163
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/24/2022

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/24/2022
• Event Location: Hospital
• Date Report to Manufacturer: 07/05/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/05/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27010 DA
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Race: White