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 PRESSURIZE". NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

Additional Manufacturer Narrative

INVESTIGATION SUMMARY: THE AFFECTED DEVICE WAS RECEIVED FOR EVALUATION. THE ROOT CAUSE WAS NOT ESTABLISHED BECAUSE THERE WAS NO INVESTIGATION DONE. NO INVESTIGATION WAS DONE BECAUSE THE PRODUCT IS AN OLD SPECIFICATION PRODUCT AND SERVICE HAS ENDED. THE SERVICE HISTORY REVIEW COULD NOT BE COMPLETED AS NO SERIAL NUMBER WAS PROVIDED.