Recipient: Philips Medizin Systeme Gmbh
Product: 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 index was evaluated as 8=moderate (on a scale of 1-12), the software defect was corrected via a revision for future production, and only the reporting hospital received field action in the form of replacement/upgrade.
Failure to establish and maintain adequate procedures in order to identify all actions needed to correct and prevent recurrence of nonconforming product and other quality problems, as required by 21 CFR 820.100(a)(3). For example:
the risk to the patient associated with the software failure of the IntelliVue monitor series, which can result in a corrupted time and date stamp was not reevaluated when 6 additional complaints were received;
FDA has received responses from Elisabeth M. George, dated December 8, 2004 and January 31, 2005 concerning our investigators’ observation 2 noted on the FDA 483. FDA has reviewed your responses and has concluded that they are inadequate for the following reasons . The documentation for reopening or adding to a CAPA investigation was not provided nor was the revision to the risk assessment process included. (A-Q2920-00126 Rev. G), which utilizes both frequency and severity to assign risk and determine a course of action . In addition to these procedures, FDA will need to evaluate the specific health risk and corrective actions for the software failure identified and determine whether resolution has been accomplish with the new process. Please provide the documentation for reopening or adding to a CAPA investigation and the revision to the risk assessment process as discussed above as well as the specific health risk and the corrective actions for the software failures identified.
Failure to establish and maintain adequate procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i). For example, failure to perform integration testing for software modules used on new product platforms failed to detect corrupted time stamps on bedside monitors and STAR algorithms.
FDA received responses from Elisabeth M. George, dated December 8, 2004 and January 31, 2005 concerning our investigators’ observation 5 noted on the FDA 483. FDA has reviewed your responses and has concluded that they are inadequate for the following reasons. The revision to the Design Process procedure (A-Q22920-0204) to allow for enhancement in the handling of integration testing was not provided. Additionally, FDA will need to review corrective action opened to investigate this issue to determine that appropriate follow-up actions were taken where needed. Please provide revisions to the design and development process which enhance awareness to integration of modules across platforms and how you have addressed validation activities. Please further provide documentation that shows evaluation of the same or similar issues across other business units and how such reviews will feed back to the design history file to determine the need for software revalidation.
Issuer: Center for Devices and Radiological Health (CDRH)
