Skip to content
Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

No adverse-event reports are linked to this device.

Recall history
InitiatedRecall #ClassStatusReasonQuantityLink basis
2013-12-05Z-0808-2014Class IITerminatedIntermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG cable connector on the DASH, PDM, and/or Tram Module. May result in reduced ECG, Respiration and arrhythmia detection performance.Distribution: Worldwide Distribution: US (nationwide) including DC and PR except SD, VT and WY; and Internationally to: ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRAZIL, CHINA, COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, EGYPT, GERMANY, UNITED KINGDOM, IRELAND, IRAQ, ISRAEL, JAMAICA, JAPAN, JORDAN, KOREA, KUWAIT, LEBANON, LITHUANIA, MARITIUS, MALDOVA, NEW ZEALAND, NIGERIA, PAKISTAN, PANAMA, PARAGUAY, PERU, POLAND, QATAR, RUSSIA, SLOVAKIA, SOUTH AFRICA, SWEDEN, SWITZERLAND, TUNISIA, UNITED ARAB EMIRATES, VENEZUELA, CHILE, CANADA, and BERMUDA.1,948 (1,834 US; 114 OUS)clearance family
Regulatory clearances

    Predicate lineage

    K011000

    Cited as predicate by: K190008

    Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

    Manufacturer compliance record
    DateTypeOutcomeFacilityCitations
    2012-02-02VAIVoluntary action indicatedGE Healthcare Finland Oy1
    Similar devices
    Select up to two to place side-by-side with this device.