PORTEX CUFF PRESSURE MONITORING

Additional Manufacturer Narrative

WHILE PERFORMING A REVIEW OF COMPLAINT FILE CN-309686, IT WAS DISCOVERED THAT THE FILE WAS INADVERTENTLY ASSESSED AS REPORTABLE. THERE WAS NO PATIENT DEATH, NO SERIOUS INJURY, AND NO EVIDENCE OF A REPORTABLE PRODUCT MALFUNCTION. THE HAZARDOUS SITUATION FOR THE GIVEN COMPLAINT DEVICE WOULD NOT LIKELY CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. REPORT REFERENCE NUMBER 3012307300-2024-07541 IS NO LONGER CONSIDERED REPORTABLE, PLEASE DISREGARD ANY REPORTS ASSOCIATED WITH IT.

Additional Manufacturer Narrative

B3. DATE OF EVENT: UNKNOWN. NO INFORMATION HAS BEEN PROVIDED TO DATE. E1 - INITIAL REPORTER EMAIL AND LAST NAME UNKNOWN. 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.

Description of Event or Problem

IT WAS REPORTED THAT WITH THE DEVICE THE MEASURED VALUE WAS INCORRECT. THERE WAS NO DISINFECTION OR STERILIZATION, AND NO INFECTIOUS DISEASE THAT OCCURRED. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM REPORTED.