MAUDE Adverse Event Report: RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD OPTICHAMBER DIAMOND; HOLDING CHAMBERS, DIRECT PATIENT INTERFACE

Model Number	1098214
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Respiratory Distress (2045)
Date of Event	11/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The optichamber diamond is available with three mask sizes - small, medium and large.Instructions for use supplied with the device states 'recommended patient population: optichamber diamond with small litetouch mask: 0 to 18 months.Optichamber diamond with medium mask: 1 to 5 years.Optichamber diamond with large litetouch mask: 5 years +.' as the device is restricted to sale by or on the order of a physician or licensed healthcare professional, it is expected that the patient be assessed for adequate fit prior to use, and appropriate mask selected.Device is not life sustaining/ supporting.No other complaints received relating to recommended sizing issues.
Event or Problem Description
Patient caregiver reported that the (b)(6) patient was admitted to hospital overnight due to use of an optichamber diamond valved holding chamber device with a small litetouch mask that was too small for the patient, and therefore patient did not get the medication needed.Patient was discharged with a larger mask.Caregiver states her daughter is doing fine now.

• Brand Name: OPTICHAMBER DIAMOND
• Common Device Name: HOLDING CHAMBERS, DIRECT PATIENT INTERFACE
• Manufacturer (Section D): RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD; chichester business park; city fields way, tangmere; chichester, PO202 FT; UK PO202FT
• MDR Report Key: 7057130
• Report Number: 9681154-2017-00020
• Device Sequence Number: 16645356
• Product Code: NVP
• UDI-Device Identifier: 00383730000336
• UDI-Public: 00383730000336
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K110293
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/09/2017

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: 1098214
• Device Catalogue Number: 1098214
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2017
• Initial Report FDA Received Date: 11/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 8 MO