Dive Brief:

• Philips is updating instructions for an ultrasound system after reporting eight serious injuries and four deaths, the Food and Drug Administration said Friday.
• The FDA, which published an early alert about Philips’ actions, said the software issue can delay the use of the portable Lumify diagnostic ultrasound system.
• Philips wrote to customers about the issue last month, recommending actions to mitigate the risks while it develops a software update to fix the problem.

Dive Insight:

The risks stem from the failure of Lumify Android or iOS applications to recognize a previously registered transducer. When that happens, the system prompts users to re-register the devices. The Lumify device cannot be used to scan patients until re-registration is complete.

Re-registration requires Wi-Fi or cellular signal access, making the issue a particular concern for devices used outside of hospitals. Lumify is intended for point-of-care use and deployed in ambulances, aircraft and field settings to scan patients. If Wi-Fi and cellular signal access is limited, users may be unable to re-register the devices. 

Philips has received reports that unexpected re-registration events have prevented scanning and delayed care to patients. The reports cover the use of Lumify in environments without Wi-Fi or cellular access. 

Loss of scanning functionality or system failure may have greater consequences for Lumify than for traditional ultrasound devices, the FDA said. That conclusion reflects Lumify’s role in real-time decision-making, triage of unstable patients and access to diagnostic capabilities in mobile, underserved or remote settings.

Delays to diagnosis or treatment could lead to serious injury or death, depending on the clinical situation and patient condition, the FDA said. As of Sept. 29, Philips had reported eight serious injuries and four deaths.

To mitigate the risk, Philips recommends that healthcare professionals only use Lumify in areas with readily accessible Wi-Fi or cellular signals unless a backup ultrasound device is immediately available. The company advises users to always have backup ultrasound devices or modalities available for care. The precautions could prevent harm while Philips assesses and fixes the cause of the connection issue.

The connection between the transducer’s USB cable and a tablet or phone may disconnect or be unstable, a Philips spokesperson wrote in an email to MedTech Dive.

Philips is developing a software update, and is also working to identify the appropriate solution to the USB connection issue, the spokesperson wrote. Philips has put together a dedicated taskforce to address the situation, including offering advice and support to customers affected by the device correction.