EQUINOX WARMER BLACK OVERLAY MEMBRANE SWITCH

Description of Event or Problem

IT WAS REPORTED THAT THE MAINTENANCE PARTS RECEIVED UNDER INVOICE NF6808 FOR THE LEVEL 1 EQUIPMENT INCLUDED TWO UNITS OF THE PANEL MEMBRANE WITH CONTROL BUTTONS PACKAGED TOGETHER WITHIN A SINGLE MANUFACTURER-LABELED BAG. HOWEVER, THE INVOICE INDICATED THAT TWO UNITS WERE EXPECTED, WHICH IMPLIES THEY SHOULD HAVE BEEN DELIVERED IN SEPARATE PACKAGES. THE IMMEDIATE ACTIONS TAKEN WERE THAT ONE OF THE TWO UNITS WAS REMOVED FROM THE ORIGINAL PACKAGING AND PLACED INTO A NEW PLASTIC BAG, WITH PROTECTIVE BUBBLE WRAP SURROUNDING THE PRODUCT. THE STATUS OF THE PRODUCT WAS UPON REMOVAL FROM PACKAGE. THERE WAS NO PATIENT INVOLVEMENT OR HARM.

Additional Manufacturer Narrative

E: PHONE NUMBER EXT. - (B)(6). 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 INFORMATION BECOMES AVAILABLE.

Additional Manufacturer Narrative

DEVICE EVALUATION: NO PRODUCT RETURNED FOR DEVICE ANALYSIS; A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURE. NO PRODUCT WAS RETURNED; THEREFORE, NO VISUAL AND FUNCTIONAL TESTS WERE PERFORMED, THE REPORTED COMPLAINT COULD NOT BE CONFIRMED, AND THE ROOT CAUSE COULD NOT BE DETERMINED. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION.