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

Device Problems Break (1069); Gas Output Problem (1266)

Patient Problems Death (1802); Hypoxia (1918); Myocardial Infarction (1969)

Event Date 02/08/2018

Event Type  Death  

Event 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
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): SMITHS MEDICAL, ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 330 coporate woods parkway; vernon hills IL 60061
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7630832
• MDR Text Key: 112076847
• Report Number: 3012307300-2018-02512
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 50351688600118
• UDI-Public: 50351688600118
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 0552
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Death; Hospitalization
• Patient Age: 95 YR