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Maquet Cardiopulmonary flags ROTAFLOW Console battery charging fault after battery-mode use

🇳🇱 IGJ · Mon 09 Nov 2026

Internal validation of replacement batteries revealed the ROTAFLOW Console can stop charging its battery once battery operation mode has been used, according to a manufacturer warning published by Dutch regulator IGJ.

Maquet Cardiopulmonary GmbH (MCP) has warned users of its ROTAFLOW Console about a battery issue found during internal validation of new replacement batteries. The Dutch health inspectorate IGJ has published the manufacturer's notice.

According to the notice, the fault can cause the device to stop charging its battery after the battery operation mode has been used. The source does not describe any patient harm, incidents or the number of devices affected.

The field safety notice (FSN) is dated 5 August 2026, and IGJ's page lists an English-language PDF of eight pages, headed with a date of 10 November 2026. IGJ describes the item as a manufacturer's warning. Manufacturers must follow their devices after they reach the market and act where users face a risk, informing both users and the inspectorate through an FSN.

The source text does not set out the corrective actions requested of users or the manufacturer's timeline for a fix. Those details are in the FSN itself, which users should consult directly.

What it means for your team

  • Facilities using the ROTAFLOW Console should obtain and read the full FSN to confirm the required actions, as the IGJ summary does not detail them.
  • Quality and risk teams may wish to check how the console is deployed and how battery operation mode is used locally, since the reported fault follows use of that mode.
  • Vigilance teams should log the FSN in their records and confirm that any related incidents are reported through normal channels.
  • The issue was found during validation of replacement batteries, which suggests battery-related changes can warrant fresh verification of charging behaviour.

Official source: IGJ ↗

Article written by VigiEye from the official source (IGJ). AI-assisted; check the source before acting.

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