Events

Field Safety Notices about HeartStart XL+ Defibrillator/Monitor

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Philips.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
  • Extra notes in the data
  • Reason
    Through internal testing and customer complaint investigations, the following xl+ software and hardware issues have been identified: software: the xl+ may fail to complete the power on sequence and continuously reboot. the xl+ may either fail to power up or may shut down unexpectedly. the xl+ may have a software version that did not reset a fail-safe monitoring component which could delay of therapy or pacing interruption. the xl+ may fail to generate verbal prompts in aed mode. hardware: the xl+ may have been manufactured with a speaker that may fail. the battery may not seat properly causing the xl+ to shut down unexpectedly or remain powered on and not acknowledge or charge the battery. the xl+ exceeds the allowable radiated emissions level for class b cispr11. the xl+ ecg signal from leads could be lost and unrecoverable. the xl+ spo2 signal may lose communication and cause the device to reboot. the xl+ battery detection system may be disrupted and cause a false low battery alarm.

Device

HeartStart XL+ Defibrillator/Monitor
  • Model / Serial
    USO1100100 to USD1101095, US11201096 to USD1203968, US11303969 to USD1309471, US11409472 to US61414022
  • Manufacturer
    Philips

Manufacturer

Philips
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    AMPMDRS