MAUDE Adverse Event Report: SMITHS MEDICAL, ASD, INC. PORTEX® O2 HUMIDIFIER; STERILE WATER FOR INHALATION USP BOTTLE; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Catalog Number	0552
Medical Device Problem Codes	Break (1069); Gas Output Problem (1266)
Health Effect - Clinical Codes	Death (1802); Hypoxia (1918); Myocardial Infarction (1969)
Date of Event	02/08/2018
Type of Reportable Event	Death
Event or Problem Description
It was reported that a patient was admitted to hospital care and patient later expired.The device a portex® o2 humidifier; sterile water for inhalation usp bottle was in the patient's home for "first aid" use.It was further reported that "on (b)(6) 2018 the son-in-law was called by the nurse of his mother-in-law, because she suffered a heart attack.When he arrived at her, she breathed heavily.He wanted to supply her with oxygen [using the device], but the oxygen did not come out of the oxygen goggles, but came off at the coupling piece (adapter) of the humidifier bottle because it was broken.The hospitalization following the event will at least make the assessment a serious event, regardless of whether the heart attack itself or the lack of oxygen was the reason." the original complaint information received was that the patient's subsequent death was "beyond doubt unrelated to the event".

• Brand Name: PORTEX® O2 HUMIDIFIER; STERILE WATER FOR INHALATION USP BOTTLE
• Common Device Name: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): SMITHS MEDICAL, ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7630832
• Report Number: 3012307300-2018-02512
• Device Sequence Number: 13918690
• Product Code: BTT
• UDI-Device Identifier: 50351688600118
• UDI-Public: 50351688600118
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/22/2018

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 0552
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2018
• Initial Report FDA Received Date: 06/22/2018
• 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: Death; Hospitalization