PORTEX CUFF PRESSURE MONITORING

Description of Event or Problem

IT WAS REPORTED THAT WITH THE DEVICE AN AIR LEAK OCCURRED. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.

Additional Manufacturer Narrative

B3 - DATE OF EVENT UNKNOWN. E1-INITIAL REPORTER 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.

Additional Manufacturer Narrative

WHILE PERFORMING A REVIEW OF COMPLAINT FILE (B)(4), 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 3012307300-2024-07408 IS NO LONGER CONSIDERED REPORTABLE, PLEASE DISREGARD ANY REPORTS ASSOCIATED WITH IT.