MAUDE Adverse Event Report: PHILIPS RESPIRONICS / RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD INEB AAD SYSTEM DRUG GUIDE FUNNEL; NEBULIZER (DIRECT PATIENT INFERFACE)

Model Number INEB AAD SYSTEM

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 01/04/2021

Event Type  malfunction  

Event Description

Patient stated her ineb device is not working.It is fully charged, but it is not functioning.We are sending pt a replacement device.No changes in breathing or pah symptoms.Advised pt to limit physical activity/over-exertion.If difficult to breathe and unrelieved by rest, pt should contact md and head to hospital.Pt verbally understands.Did the patient provide any additional details as to what was wrong with the device? no any error codes she was getting? no was she directed to return the malfunctioning device? awaiting return authorization from manufacturer.Reported to (b)(6) by pt/caregiver.

• Brand Name: INEB AAD SYSTEM DRUG GUIDE FUNNEL
• Type of Device: NEBULIZER (DIRECT PATIENT INFERFACE)
• Manufacturer (Section D): PHILIPS RESPIRONICS / RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD
• MDR Report Key: 11462673
• MDR Text Key: 239715399
• Report Number: MW5099934
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: INEB AAD SYSTEM
• Device Lot Number: 2011N214020
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 55 YR