First reported 24 Nov 2014•Latest report 26 May 2016
Definition
What this concern includes
Includes failures of controls specifically dedicated to safe oxygen-concentrator operation, including malfunction procedures, oxygen-flow monitoring or alarms, user instructions and required response or escalation when the device fails or oxygen delivery is interrupted.
Not included
Excludes generic clinical-equipment availability, maintenance or serviceability deficiencies unless they specifically concern oxygen-concentrator safety controls.
Excludes failures involving other oxygen-delivery equipment, such as portable cylinders or oxygen masks, unless the assertion explicitly concerns the oxygen concentrator.
Excludes failures limited to prescribing oxygen, selecting an oxygen flow or documenting oxygen therapy when no oxygen-concentrator control is deficient.
Excludes generic training, staffing, documentation or communication deficiencies that are not directly tied to safe oxygen-concentrator operation or malfunction response.
Reports
2
Distinct published reports
Individual concerns
3
A report can raise multiple concerns
Date range
2014–2016
First to latest report issue date
Stated actions
1
Described in published responses
Reports over time
Reports over time
Reports about this concern issued each year.
* 2026 is projected from reports observed to 7 Sep 2026.
Most frequent recipients
Most frequent recipients
Reports about this concern sent to each recipient.
County Durham and Darlington NHS Foundation Trust1
Dolby Vivisol1
Invacare Limited1
Medicines and Healthcare products Regulatory Agency1
Salter Labs1
Company1
Medicines and medical devices regulator1
NHS trust1
Concerns and responses across reports
Only concerns grouped under this recurring concern are included. Select any concern, action or position to view the source wording.
County Durham and Darlington
Concerns raised2
Failure to specify action when an oxygen concentrator is not working correctly
Failure to specify checks of oxygen concentrator output
This report raised 4 other concerns. They are not shown here because they do not form part of this recurring concern.
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
Respondent positions A position is what a respondent says about the concern when they do not describe a specific action.1
Position
The Oxylitre instructions for use provide sufficient pre-use inspection guidance, making additional specific leak-test instructions unnecessary.
Stated by Medicines and Healthcare products Regulatory AgencyExisting arrangements considered sufficientThe respondent said that existing arrangements were sufficient, so no further action was needed.
Surrey
Concerns raised1
Absence of a visual or audible alarm indicating loss of oxygen flow to the nasal cannula
This report raised 2 other concerns. They are not shown here because they do not form part of this recurring concern.
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
Actions described in response An action is something a respondent says it has done, is doing, or plans to do in response to the concern raised.1
Action
Assess whether an alarm can detect oxygen-flow loss caused by an improperly engaged humidifier cap.
Stated by Invacare (UK) LimitedStated completedThe respondent said that this action was complete when they made their response on 24 November 2014.
Respondent positions A position is what a respondent says about the concern when they do not describe a specific action.6
Position
The humidifier’s existing safety valve and leak-test instructions provide warnings for blockages and leaks, including cross-threading-related leaks.
Stated by Salter LabsExisting arrangements considered sufficientThe respondent said that existing arrangements were sufficient, so no further action was needed.
Position
The concentrator manufacturer is responsible for addressing the absence of a visual or audible alarm for lost oxygen flow.
Stated by Salter LabsRedirects responsibilityThe respondent said that another organisation was responsible for deciding or taking action.
Position
Equipment manufacture and design concerns fall outside the company’s functions, so it cannot respond to them.
Stated by Dolby VivisolOutside remitThe respondent said that this matter was outside its role or authority.
Position
Equipment manufacture and design concerns should be addressed by the relevant manufacturers, Invacare and Salter Labs.
Stated by Dolby VivisolRedirects responsibilityThe respondent said that another organisation was responsible for deciding or taking action.
Position
Existing alarms detect relevant concentrator faults, comply with applicable standards, and are considered sufficient without additional alarms.
Stated by Invacare (UK) LimitedExisting arrangements considered sufficientThe respondent said that existing arrangements were sufficient, so no further action was needed.
Position
An alarm detecting oxygen loss at the humidifier would be technically complex and introduce unacceptable risks and inconvenience without sufficient benefit.
Stated by Invacare (UK) LimitedUnable to actThe respondent said that a constraint prevented them from taking the relevant action.
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Includes failures of controls specifically dedicated to safe oxygen-concentrator operation, including malfunction procedures, oxygen-flow monitoring or alarms, user instructions and required response or escalation when the device fails or oxygen delivery is interrupted.
