Customer event report form - HeartSine

FORM MUST NOT CONTAIN INFORMATION THAT COULD IDENTIFY THE PATIENT Please do not provide any identifiable information, such as patient name, address or location of hospital.

Your Name(Required)

Your Email(Required)

Patient Information

Gender(Required)

Male

Female

Non-Binary/Third Gender

Age in Years(Required)

Weight (Estimation)

(Please indicate Lb or Kg)

Event Information

Country(Required)

Date of Use(Required)

Time of Use (Local)

Was the event witnessed?

Yes

If yes, relationship to patient?

Was CPR performed by bystander prior to AED switch on?

Yes

If yes, for how many minutes?

What was the rescuer response time, in minutes (from SCA to retrieving AED)?

Was patient breathing prior to commencing CPR?

Yes

Unknown

Did the patient have a pulse prior to commencing CPR?

Yes

Unknown

Was a shock delivered?

Yes

Location Type for Resuscitation Attempt

Please select one.(Required)

Details (if unknown, enter N/A)(Required)

Please indicate the specific type of location (gym, dentist office, restaurant, etc.), providing as much information as possible. DO NOT PROVIDE PLACE NAME, ADDRESS OR GEOGRAPHICAL LOCATION.

Patient Outcome

Outcome (Please select one.)(Required)

Details (if unknown, enter N/A)(Required)

Please provide any additional information on rescue attempt (when did ambulance arrive, actions taken). DO NOT PROVIDE CITY, OR HOSPITAL NAME OR ADDRESS. Please do not provide identifiable information such as city names, hospital names or addresses.

Patient Pre-Existing Medical Condition (if known)

Condition

Diabetes Mellitus

Hypertension

Hyperlipidaemia

Implanted Pacemaker

Please check all that apply.

Please list other known conditions.

Please upload your event file here (.evo file).(Required)

Accepted file types: evo, Max. file size: 244 MB.

Note: A PDF file will not be accepted.

Event file

The event file, downloaded using SAVER EVO software, must be uploaded with this form. Please use the following filename structure: Device serial number_Date of event (MM-DD-YYYY). If you need assistance downloading the file, please contact heartsinesupport@stryker.com.

Device Information

Device Type(Required)

Device Serial Number(Required)

Pad-Pak Information

Pad-Pak Type(Required)

Pad-Pak Lot/Serial Number

Pad-Pak Expiration Date

Reporter Information

Event Reporter Name(Required)

Telephone

Email(Required)

Distributor Name

User Information

Was user trained? (if known)

Yes

Training Provider (if known)

Terms

Following are the terms for the Free Pad-Pak and Forward Hearts programs. 1. Please do not attach any picture, audio and/or video recording related to the reported event. 2. Event must be a sudden cardiac arrest to qualify. (Event is reviewed by Stryker Clinical team whose decision is final.) 3. Please refer to heartsine.com for the complete list of requirements to qualify for Free Pad-Pak and/or Forward Hearts after a Stryker AED has been used during a sudden cardiac arrest resuscitation. 4. The person completing this form will ensure compliance with local privacy regulations, and agrees to ensure no identifiable information is contained in this form.

Additional Comments/Suggestions