Recipient: Philips Medizin Systeme GmbhProduct: IntelliView patient bedside monitors Date: 5/6/05 CAPA investigation 4921 for complaints M2003-009925 and M2003-010130 received from the same hospital regarding a failure in the arrhythmia analysis software was not further investigated to determine whether similar defects in heart rate monitoring were reported by other facilities. Documentation shows the hazard/ risk...Read More
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