PORTEX CUFF PRESSURE MONITORING

Additional Manufacturer Narrative

B3: DATE OF EVENT IS UNKNOWN. 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 THE DEVICE CANNOT BE MEASURED. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

Additional Manufacturer Narrative

AFTER FURTHER REVIEW, THE REPORTED ITEM# WAS FOUND TO BE A PFG. THIS DEVICE DOES NOT HAVE A 510K OR SALES IN THE UNITED STATES, NOR ARE THERE ANY SUBSTANTIALLY SIMILAR DEVICES SOLD IN THE US. THEREFORE, NO REGULATORY REPORTING IS REQUIRED TO THE FDA FOR THIS ISSUE. THE EMDR WAS REPORTED IN ERROR AND WILL BE CANCELLED.