CADD-SOLIS WIRELESS COMMUNICATION MODULE

Description of Event or Problem

IT WAS REPORTED THAT THE DEVICE HAD ¿WIRELESS MODULE INTERMITTENT CONNECTION WHEN POLE CLAMP CAPTURE BRACKET WAS ATTACHED.¿ PER REPORTER THE DEVICE OPERATES UNTIL BRACKET WAS ATTACHED. THE PRODUCT FAULT OCCURRED UPON OPENING. THE EVENT HAPPENED AT THE HOSPITAL. THE ISSUE WAS NOT RESOLVED, AND THE STEPS TAKEN TO RESOLVE THE ISSUE WAS TO REMOVE AND REINSTALL THE POLE CLAMP CAPTURE BRACKET. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.

Additional Manufacturer Narrative

D4 - LOT #: POSSIBLE LOT # 19222261. H3: INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.