I-NEB SYSTEM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-16 for I-NEB SYSTEM manufactured by Respironics, Inc..

Event Text Entries

[183965961] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	MW5093790
MDR Report Key	9840588
Date Received	2020-03-16
Date of Report	2020-03-05
Date of Event	2020-03-04
Date Added to Maude	2020-03-17
Event Key	0
Report Source Code	Voluntary report
Manufacturer Link	N
Number of Patients in Event	0
Adverse Event Flag	3
Product Problem Flag	3
Reprocessed and Reused Flag	3
Reporter Occupation	OTHER HEALTH CARE PROFESSIONAL
Health Professional	3
Initial Report to FDA	3
Report to FDA	3
Event Location	3
Single Use	0
Previous Use Code	0
Event Type	3
Type of Report	3

Device Sequence Number: 1

Brand Name	I-NEB SYSTEM
Generic Name	NEBULIZER (DIRECT PATIENT INTERFACE)
Product Code	CAF
Date Received	2020-03-16
Lot Number	(01)00383730000
Operator	LAY USER/PATIENT
Device Availability	Y
Device Sequence No	1
Device Event Key	0
Manufacturer	RESPIRONICS, INC.

Device Sequence Number: 101

Brand Name	10MCG/ML
Product Code	---
Date Received	2020-03-16
Device Sequence No	101
Device Event Key	0

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-03-16