MAUDE Adverse Event Report: PHILIPS RESPIRONICS / RESPIRONICS INC. I-NEB++ DRUG GUIDE FUNNEL; NEBULIZER (DIRECT PATIENT INTERFACE)

Device Problem Noise, Audible (3273)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Patient states her i-neb nebulizer device is old and makes a rattling noise like a baby rattle (could not tell me the exact date when the noise started).We sent her a device in (b)(6) 2021 so it's not even at the 5 year mark for replacement yet.She said it still delivers her doses, but she wants a new one due to the noise.Nothing in the troubleshooting guide for rattling noise.She provided serial number of (b)(4).Not sure if these are correct i explained the serial number was on the bottom of the device but she said she could not locate it and just read me all the numbers she could see.Requested the same day shipment for a new device pending supervisor approval.Patient said device still works and she has not missed any doses and no adverse events reported.No other information provided.Reported to (b)(6) by pt/caregiver.

• Brand Name: I-NEB++ DRUG GUIDE FUNNEL
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): PHILIPS RESPIRONICS / RESPIRONICS INC.
• MDR Report Key: 14593113
• MDR Text Key: 293461866
• Report Number: MW5110078
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 00081721102758
• UDI-Public: 081721102758
• Combination Product (y/n): N
• 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: 05/27/2022

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/02/2022
• Patient Sequence Number: 1
• Patient Sex: Female