Hil-rom Isolette C2000 Infant Incubators

Hil-rom 6/25/98 Isolette C2000 Infant Incubators

Failure to assure that all inspection and testing equipment is suitable for its intended purposes and is capable of producing valid results. The inspection revealed that the _____ automated simulator test has not been updated to keep current with hardware and software changes made to the C2000 device. (FDA 483 Observation 2)

We acknowledge the fact that, on May 8, 1998, your firm voluntarily ceased distributing the C2000 in response to our ultimate determination that these devices represent a moderate risk of serious adverse health consequences and that your firm initiated a Class II recall (consisting of user notification) of devices currently on the market. As representatives from this office have previously conveyed to you and other members of your staff, we consider this recall an interim fix until outstanding CGMP deficiencies can be resolved.

We also acknowledge your efforts to validate the software associated with the _____ automated simulator. However, the inspection revealed that the _____ has both software and hardware components. These hardware components also require validation. In addition, we are unable to fully review the proposed additional production/quality control (QC) tests discussed in the response because the information provided does not include a diagram of the equipment and instrument set-up. In addition, it appears that these additional tests may also depend upon a validated _____ simulator. If you intend to use these tests when you resume shipping this device, then we request that you provide us with the test set-up and also clarify whether or not the additional tests use the _____ simulator.

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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