MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. OXYGEN MASK HIGH CONCENTR. 7FT. TUBING REBREATHER ADULT 25/CA; MASK, OXYGEN, NON-REBREATHING

Catalog Number 001123

Device Problems Disconnection (1171); Fitting Problem (2183); Defective Component (2292)

Patient Problems Death (1802); Shock (2072)

Event Type  Death  

Manufacturer Narrative

Customer has not yet returned the device to the manufacturer for device evaluation.When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation.

Event Description

It was reported immediately after opening the oxygen mask high concentration 7 foot tubing rebreather the user found the tubing tip was 'firm' and it was difficult to connect to the oxygen flowmeter nipple.The user also reports the patient was 'in shock', underwent resuscitation and temporarily recovered.The rebreather oxygen mask tubing disconnected 3 to 4 times from the oxygen flowmeter during the two hours it was used.It was further reported the patient expired and the doctor stated the cause of death was not due to the disconnection of the oxygen tube to the flowmeter, however 'the association was not entirely denied'.

• Brand Name: OXYGEN MASK HIGH CONCENTR. 7FT. TUBING REBREATHER ADULT 25/CA
• Type of Device: MASK, OXYGEN, NON-REBREATHING
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 9124 polk lane; suite 101; olive branch MS 38654
• Manufacturer Contact: lisa perz ; smiths medical asd, inc.; 6000 nathan lane north; minneapolis,, MN 55442 ; 7633833074
• MDR Report Key: 6250556
• MDR Text Key: 64776814
• Report Number: 3012307300-2017-00167
• Device Sequence Number: 1
• Product Code: KGB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Catalogue Number: 001123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death