MAUDE Adverse Event Report: RESPIRONICS, INC. I-NEB SYSTEM; NEBULIZER (DIRECT PATIENT INTERFACE)

Lot Number (01)00383730000

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 03/04/2020

Event Type  malfunction  

Event Description

Spontaneous call, pt stating - i-neb device is displaying error code 22.No averse effect reported.Pt reported sn (b)(4).Pt does not have backup.Did the pt have backup device they were able to switch to? no."if no, what was the pt instructed to do in able to continue their infusion? not an infusion.Is the infusion life-sustaining? not an infusion." what is the outcome of the event: ongoing.Did the reported product fault occur while in use with the pt? no.Did the product issue cause or contribute to pt or clinical injury? no.Is the actual device available for investigation? yes.Did we (mfr) replace the device? yes.Reported to (b)(6) by pt/caregiver.

• Brand Name: I-NEB SYSTEM
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): RESPIRONICS, INC.
• MDR Report Key: 9840588
• MDR Text Key: 183965961
• Report Number: MW5093790
• 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: 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: (01)00383730000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR