MAUDE Adverse Event Report: NEBULIZER COMPRESSOR MACHINE; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number	C N -02 M N
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	09/10/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Got first nebulizer machine on (b)(6) 2018 called (b)(6) pharmacy on (b)(6) 2018, was told by them to return it.The nebulizer was returned because it had strong chemical smell coming from the machine (without the hose hooked to it).Could taste the chemical in my mouth.I used the 2nd machine only 2 days because it too had a strong chemical taste and smell coming from it also.Was told by (b)(6) pharmacy before i return the 2nd machine, i had to call cardinal health and get the ok from them.Cardinal health said it was ok to return the 2nd machine to (b)(6) pharmacy so i did on (b)(6) 2018.I got a replacement nebulizer machine for a different mfr(philips) and there was no chemical smell or taste from it.Cardinal health.

• Brand Name: NEBULIZER COMPRESSOR MACHINE
• Common Device Name: NEBULIZER (DIRECT PATIENT INTERFACE)
• MDR Report Key: 8254019
• Report Number: MW5083186
• Device Sequence Number: 2056149
• Product Code: CAF
• UDI-Device Identifier: 10885380116193
• UDI-Public: 10885380116193
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 01/12/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: C N -02 M N
• Device Catalogue Number: ZRCNO1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/15/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 62 YR
• Patient Weight: 82