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

Lot Number 81294662

Device Problem Charging Problem (2892)

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

Event Type  malfunction  

Event Description

Spontaneous call from daughter, serial/lot number (b)(4).Device no longer "holds a charge." device was not in use when fault occurred.No lapse in therapy or side effects due to malfunction.Sending replacement device and patient will return malfunctioning device.Patient does have back up device.No other information is known, or was reported.Reported to (b)(6) by pt/caregiver.

• Brand Name: I-NEB NEBULIZER
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): PHILIPPS RESPIRONICS / RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD
• MDR Report Key: 10343946
• MDR Text Key: 201272252
• Report Number: MW5095807
• 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: 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 81294662
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1