Regulatory Open Forum

Hi,

This is with reference to some devices sold almost 14 years ago. 5 years ago , during servicing, the service technician conducted some unauthorised repair which probably led to  an event 2 weeks ago (adverse event?) , no serious injury caused but could have the potential to cause one . In this case , there was no device fault , our investigation in the past have the evidence that no repair /changes were applicable to this design. Will this qualify as an adverse event ?

After 14 years it's difficult to trace which devices would have undergone such unauthorised repair.

Should we  handle such cases as they come or do we need to get the status of devices sold during this time and get the service history?

Also if we got the devices back to its original design , would this  amount to a recall ?

Thanks & Regards,

Rashmi Pillay
Regulatory Affairs Associate

Ellex 

3-4 Second Avenue

Mawson Lakes SA, 5095

T + 61 8 7074 8105
E  rpillay@ellex.com

W ellex.com

.............................................................................
 
One Powerful Vision.

Confidentiality: This e-mail is from Ellex Medical Pty Ltd, ABN 35 008 276 060. The contents are confidential and intended only for the named recipient of this e-mail. If the reader of this e-mail is not the intended recipient you are hereby notified that any use, reproduction, disclosure or distribution of the information contained in the e-mail is prohibited. Viruses: Any loss/damage incurred by using this material is not the sender's responsibility. No warranty is made that this material is free from computer virus or other defect. Ellex Medical Pty Ltd entire liability will be limited to resupplying the material. If you have received this e-mail in error, please reply to us immediately and delete the document. 

Hi,

This is with reference to some devices sold almost 14 years ago. 5 years ago , during servicing, the service technician conducted some unauthorised repair which probably led to  an event 2 weeks ago (adverse event?) , no serious injury caused but could have the potential to cause one . In this case , there was no device fault , our investigation in the past have the evidence that no repair /changes were applicable to this design. Will this qualify as an adverse event ?

After 14 years it's difficult to trace which devices would have undergone such unauthorised repair.

Should we  handle such cases as they come or do we need to get the status of devices sold during this time and get the service history?

Also if we got the devices back to its original design , would this  amount to a recall ?

Thanks & Regards,

Rashmi Pillay
Regulatory Affairs Associate

Ellex 

3-4 Second Avenue

Mawson Lakes SA, 5095

T + 61 8 7074 8105
E  rpillay@ellex.com

W ellex.com

.............................................................................
 
One Powerful Vision.

Confidentiality: This e-mail is from Ellex Medical Pty Ltd, ABN 35 008 276 060. The contents are confidential and intended only for the named recipient of this e-mail. If the reader of this e-mail is not the intended recipient you are hereby notified that any use, reproduction, disclosure or distribution of the information contained in the e-mail is prohibited. Viruses: Any loss/damage incurred by using this material is not the sender's responsibility. No warranty is made that this material is free from computer virus or other defect. Ellex Medical Pty Ltd entire liability will be limited to resupplying the material. If you have received this e-mail in error, please reply to us immediately and delete the document. 

Hi,

This is with reference to some devices sold almost 14 years ago. 5 years ago , during servicing, the service technician conducted some unauthorised repair which probably led to  an event 2 weeks ago (adverse event?) , no serious injury caused but could have the potential to cause one . In this case , there was no device fault , our investigation in the past have the evidence that no repair /changes were applicable to this design. Will this qualify as an adverse event ?

After 14 years it's difficult to trace which devices would have undergone such unauthorised repair.

Should we  handle such cases as they come or do we need to get the status of devices sold during this time and get the service history?

Also if we got the devices back to its original design , would this  amount to a recall ?

Thanks & Regards,

Rashmi Pillay
Regulatory Affairs Associate

Ellex 

3-4 Second Avenue

Mawson Lakes SA, 5095

T + 61 8 7074 8105
E  rpillay@ellex.com

W ellex.com

.............................................................................
 
One Powerful Vision.

Confidentiality: This e-mail is from Ellex Medical Pty Ltd, ABN 35 008 276 060. The contents are confidential and intended only for the named recipient of this e-mail. If the reader of this e-mail is not the intended recipient you are hereby notified that any use, reproduction, disclosure or distribution of the information contained in the e-mail is prohibited. Viruses: Any loss/damage incurred by using this material is not the sender's responsibility. No warranty is made that this material is free from computer virus or other defect. Ellex Medical Pty Ltd entire liability will be limited to resupplying the material. If you have received this e-mail in error, please reply to us immediately and delete the document.