MAUDE Adverse Event Report: VENTAVIS INEB AAD SYST; NEBULIZER (DIRECT PATIENT INTERFACE)

Device Problems Device Displays Incorrect Message (2591); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Solicited call: he keeps getting error number 55 (no medicine) on his device.It happened twice today and a few times earlier (sn (b)(4)), patient did confirm he is holding the device upright on a flat.Surface to add medication.He did try resetting the error by pressing the on button to do the treatment.Per pt he holds the on button for 5 seconds to clear the error message, however it pops back up during treatment.Patient confirms he has been getting his treatments and haven¿t missed any doses, he just had to use multiple vials to clear the error message.Did the reported product fault occur while in use a patient? yes.Did the product issue cause or contribute to patient or clinical injury? no.Is the actual device available to be returned for investigation? yes.Did we replace device? yes.Reported to (b)(6) by: patient/caregiver.

• Brand Name: VENTAVIS INEB AAD SYST
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• MDR Report Key: 12460721
• MDR Text Key: 271453935
• Report Number: MW5103868
• 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: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1