MAUDE Adverse Event Report: RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD. I-NEB PH UNIT; NEBULIZER

Model Number R1080086

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 10/05/2021

Event Type  Injury  

Event Description

The manufacturer became aware that a user was unable to get the i-neb to nebulize the medication.It is unclear if the user was in the hospital at the time of the event or went to the hospital after the event.The user was able to finish the treatment with an alternate unit.There was no serious patient harm or injury reported.No product was returned for investigation.A follow up report will be submitted upon completion of the manufacturer's investigation.

• Brand Name: I-NEB PH UNIT
• Type of Device: NEBULIZER
• Manufacturer (Section D): RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD.; chichester business park; city fields way, tangmere; chichester, PO20 2FT; UK PO20 2FT
• Manufacturer (Section G): RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD.; chichester business park; city fields way, tangmere; chichester, PO20 2FT; UK PO20 2FT
• Manufacturer Contact: rod mel ; chichester business park; city fields way, tangmere; chichester, PO20 -2FT ; UK PO20 2FT
• MDR Report Key: 12661181
• MDR Text Key: 277277210
• Report Number: 9681154-2021-00017
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• PMA/PMN Number: K102454
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial
• Report Date: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: R1080086
• Device Catalogue Number: R1080086
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization