MAUDE Adverse Event Report: RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD I NEB; MESH NEBULIZER

Model Number	85-149
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Respiratory Distress (2045)
Date of Event	01/07/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient believed this device had something wrong and the treatment times were increasing.It was also reported that the patient presented to hospital and was admitted.(b)(4).

• Brand Name: I NEB
• Common Device Name: MESH NEBULIZER
• Manufacturer (Section D): RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD; chichester business park; city fields way, tangmere; chichester, west sussex PO20 2FT; UK PO20 2FT
• MDR Report Key: 7296252
• Report Number: 9681154-2018-00006
• Device Sequence Number: 877344
• Product Code: CAF
• UDI-Device Identifier: 00383730000978
• UDI-Public: 00383730000978
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K042991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 02/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 85-149
• Device Catalogue Number: 85-167
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2018
• Initial Report FDA Received Date: 02/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VENTAVIS
• Outcome Attributed to Adverse Event: Hospitalization