MAUDE Adverse Event Report: RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD VENTAVIS INEB AAD SYST; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number 85-167

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Spontaneous call from patient states the device is not vibrating like it normally does and does not know what is going on.Asked if charged- she said she knows when its charged but its just not vibrating like before- new ineb was sent to pt (she did not have information on the old one- said she can't see it well).No further questions at this time.Reported to (b)(6) by pt/caregiver.

• Brand Name: VENTAVIS INEB AAD SYST
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD
• MDR Report Key: 12660024
• MDR Text Key: 277444906
• Report Number: MW5104720
• Device Sequence Number: 1
• Product Code: CAF
• 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: 10/11/2021

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
• Device Operator: No Information
• Device Model Number: 85-167
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/18/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1