Formal CFForm R1.2

Reference Procedures:
Manage Customer Feedback 7.1.4 (R23.1)
Revision 1.2

As a submitter of feedback to Philips, enter all the required information into the form and select “submit” when complete. Based on the submitter country selected, the Customer Feedback Form will be send to the applicable functional account.

Required fields are highlighted with red !!. Required fields need to be completed before leaving the page or final submission of the Form. If the information requested is not available, simply state not applicable and provide a brief explanation.

This feedback form is not required if there is a Corrective Maintenance (CM) Service Work Order (SWO) for the event, except for the following conditions, in which case the feedback form should be completed: Initial call indicated a non-safety event (Was any Patient or User harmed = "No" or Unknown") and a Philips employee learns that a safety event did occur, or there was damage to property or the environment.

For all other feedbacks not resulting in Corrective Maintenance Service Work Orders; cases in Consumer Contact Centers or Repair-Return cases, but meets the definition of a customer feedback, this feedback form shall be completed.

Note: If customer requests a formal letter response, a Customer letter will only be provided if a CUSTOMER requested a formal response.

When the Submitter of the form requests a response, an internal investigation summary can be provided.

!! Select the most appropriate Type of Feedback that you want to submit with this form.

Product Feedback
Non-Product Feedback

!! Please provide a very short summary of the problem.

!! Describe what is the main reason for providing the customer feedback.

Please indicate what was expected from the product or the service Philips provided and what was the perceived result.

Character limit: 5000.

!! What was the impact or result of the product issue or underperforming service?

Character limit: 5000.

!! Describe how the product was being used at the time of the issue/event?

Character limit: 5000.

Was the product/device in Clinical Use at the time of the event?

Yes
No
Unknown

Did the issue happen during clinical diagnosis or treatment?

Yes
No

!! Was the clinical procedure continued, stopped, or restarted?

Continued
Stopped
Stopped and restarted

!! How often does the issue happen?

!! Describe the impact to the patient?

!! If any, what actions were taken to fix (or attempt to fix) the issue?

!! Please choose the best fitting category for the Non-Product Feedback.

!! Please specify the "Other" category of Non-Product Feedback. Examples are: People, Process, Parts, 3rd party, etc ...

If this is known, was the customer feedback related to a Philips internal process or procedure?
If known, provide document name and document number.

If applicable, include the list of all devices being used at the time of the event.

!! Describe the source of the customer feedback that is the main reason for submitting this feedback form.
Please choose the best option.

!! Is the date of the event known?

Yes
No

!! Indicate the date that the event or problem first occurred. (Date should be today or in the past, cannot be future date).
Field format in mm/dd/yyyy

Format: mm/dd/yyyy

You stated that the date of the event is unknown. Please specify the reason. If unknown, fill in "unknown" or "asked but unknown".

!! Provide the date that any employee working for Philips was notified or a Philips owned system was filled related to the event.
Date should always be today or in the past.

Format: mm/dd/yyyy

!! The Become Aware Date date is the date that any employee of Philips became aware of the event related to a Philips product or could have become aware of the event (eg. the issue is loaded into a Philips system).

Is the Become Aware Date known?

Yes
No

!! Provide the date any Philips employee becomes aware of a potentially reportable event. The information suggests that a device has caused or could lead to death or serious injury.

Date should always be today or in the past.

Field format in mm/dd/yyyy

Format: mm/dd/yyyy

!! You stated that the Become Aware Date is unknown. Please specify the reason. If unknown, fill in "unknown" or "asked but unknown".

!! Provide the Feedback Type that fits best. Only select one answer. If there are multiple feedback types possible, create multiple customer feedback forms.

!! Provide the Feedback domain that fits best.
Multiple options can be selected, if these options are related to one individual event. A separate form should be submitted for each individual event or each unique device (serial number).

Privacy issues are related to the personal data. Cyber Security issues can be related to physical-, information- or IT- related security.

A Domain represents a specific Philips process that which outcome is the reason for proving the customer feedback.

Note: Select Legal as well if the reporter indicated/alleged a death, serious injury, property damage, or hinted the possibility of any legal involvement – either from Plaintiff’s counsel or governmental entity (such as a police force or coroner/medical examiner).

!! If "Other" was selected as Feedback domain then please provide details on the Domain type .

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