MAUDE Adverse Event Report: RESPIRATORY DRUG DELIVERY (UK) LTD. I-NEB - NEBULIZER; NEBULIZER (DIRECT PATIENT INTERFACE)

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/06/2020

Event Type  malfunction  

Event Description

Spontaneous call, spouse states that device stopped working yesterday.Spouse is at work and does not have serial number on hand.Spouse reports no changes in breathing.No other info known.Is the actual device available for investigation? yes.Did we replace device? yes.Did the pt have a backup device they were able to switch to? yes.Reported (b)(6) by pt/caregiver.

• Brand Name: I-NEB - NEBULIZER
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): RESPIRATORY DRUG DELIVERY (UK) LTD.
• MDR Report Key: 9728765
• MDR Text Key: 180307262
• Report Number: MW5093068
• 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: 02/07/2020

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/18/2020
• Patient Sequence Number: 1
• Patient Age: 61 YR