Important Safety Alerts

Important Safety Alerts

Medical Device Safety Alert: Getinge MAQUET CARDIOSAVE hybrid and MAQUET CARDIOSAVE rescue

14 Sep 2021

Getinge has issued a medical device safety alert concerning its MAQUET CARDIOSAVE hybrid and MAQUET CARDIOSAVE rescue [Product Codes: D998-00-0800-52, All Serial Numbers All].

Two issues are reported by the manufacturer:

  1. Helium Indicator Inaccuracy in the Presence of Continuous EMC Disturbances
    • During Electromagnetic Compatibility (EMC) testing at an external lab, the manufacturer personnel determined that in the presence of some radiated RF disturbances, the Helium Indicator on the Cardiosave IABP would intermittently over-report the remaining Helium Capacity.
    • Potential sources of interference include: radio communication, cell phone, Wi Fi, RFID equipment and equipment that does not meet current electromagnetic compatibility standards.
  2. Shutdown Upon Battery Removal
    • The device may unexpectedly shut down when the device is running on AC power, only one battery is installed in the IABP, and the battery is physically removed while the battery is being charged. An audible sudden shutdown alarm will sound if this condition occurs. Unexpected shutdown can only happen while in Hybrid Configuration when all four of the below conditions are met:
      1. IABP is running on AC power and charging a single battery in voltage charging mode.
      2. The other battery bay is empty, i.e. no battery is inserted into the second battery bay.
      3. The battery is ejected while a system signal erroneously reports the AC power supply is low, this will only happen intermittently when the first two conditions are met.
      4. Battery is ejected when all above conditions are met.
    • According to the manufacturer, an unexpected shutdown upon battery removal cannot occur for Cardiosave Rescue.

Users are asked to examine their inventory immediately to determine if they have the affected device mentioned above. Affected users should follow the recommended actions shown on the Field Safety Notice issued by the manufacturer. All current and potential affected users should be informed of the notice.

The manufacturer is developing a hardware and software correction to address this issue.

According to the local suppliers the affected products are distributed in Hong Kong.

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 14 Sep 2021

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