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International Medical Devices Database
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Recall of Siesta i TS machine(P/N # 866163/10653-00) with a serial number within the following range:200550022 to 200949001AM5153237 to AM5156683DK25100001 to DK43000256
According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Proact Medical Systems (Australia) Pty Ltd.
What is this?
A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.
Learn more about the data here-
Type of Event
Recall
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Event ID
RC-2015-RN-00707-1
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Event Risk Class
Class II
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Event Initiated Date
2015-08-06
- Event Country
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Event Source
DHTGA
- Event Source URL
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Notes / Alerts
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia. -
Extra notes in the data
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Reason
During internal review, philips identified that it was not explicitly described in the instructions for use that the o2 test must be done as part of the daily check to ensure that the machine measures the o2 concentration in the fresh gas correctly, and can deliver the desired o2 concentration in the fresh gas to the patient.Incorrect measurement of o2 concentration in the fresh gas or o2 concentration in the fresh gas not at desired level, can potentially cause hypoxia to the patient.
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Action
Review the Recall for Product Correction and the update to the IFU and ensure that the changes are understood and that all personnel using the device are informed about the content in this Recall for Product Correction. This action has been closed-out on 17/08/2016.
Device
Siesta i TS machine(P/N # 866163/10653-00) with a serial number within the following range:200550...
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Model / Serial
Siesta i TS machine(P/N # 866163/10653-00) with a serial number within the following range:200550022 to 200949001AM5153237 to AM5156683DK25100001 to DK43000256ARTG Number: 176848
- Manufacturer
Manufacturer
- Manufacturer Parent Company (2017)
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Source
DHTGA