Communicate urgent safety information to users requiring immediate protective actions.
Device Information | Description |
---|---|
Device Name | CardioWatch Pro Mobile App |
Device UDI-DI | (01)04012345123456 |
Manufacturer Name | CardioWatch Technologies GmbH |
Single Registration Number (SRN) | DE-MF-000012345 |
Device Description | Mobile application for continuous cardiac rhythm monitoring and arrhythmia detection in ambulatory patients |
Associated Devices Affected | CardioWatch Pro Hardware Sensor (Model CW-100) when used with affected app version |
Risk Information | Description |
---|---|
Description of Product Issue | Software algorithm error in version 3.2.1 causing false positive arrhythmia alerts in approximately 2% of monitoring sessions |
Hazard Resulting from Issue | Unnecessary emergency medical interventions, patient anxiety, healthcare system burden, and potential delayed response to actual emergencies |
Likelihood of Risk | Moderate - affects 2% of monitoring sessions, with higher incidence in patients with baseline heart rate variability |
Risk to Users/Patients | Patients: Unnecessary stress, emergency room visits, potential medical procedures. Healthcare providers: Resource allocation issues, diagnostic confusion |
Additional Information | Issue identified through post-market surveillance analysis of user reports. Root cause: algorithm sensitivity threshold error introduced in version 3.2.1 update |
Action Information | Description |
---|---|
Action to be Taken by User | Immediately update CardioWatch Pro app to version 3.2.2 (available now). Verify alert settings are configured correctly. Contact physician if you received false alarms in the past 3 weeks |
User Action Timeline | Update app within 48 hours of receiving this notice |
Customer Reply Required | Yes - Confirm app update completion via email to safety@cardiowatch.com or through in-app notification |
Action Taken by Manufacturer | Released corrected software version 3.2.2 with fixed algorithm. Implementing enhanced testing protocols for future releases. Notifying regulatory authorities and healthcare networks |
Manufacturer Action Timeline | Software fix released March 20, 2024. Enhanced testing protocols implemented by April 1, 2024 |
Information for Lay Patient or User | For patients: Update your app immediately. If you visited emergency care due to CardioWatch alerts in the past 3 weeks, inform your doctor about this notice. Continue normal monitoring - the device remains safe and effective with the update |
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