PORTEX CUFF PRESSURE MONITORING

Additional Manufacturer Narrative

OTHER, OTHER TEXT: D10. DEVICE AVAILABLE FOR EVALUATION; H3. DEVICE EVALUATED BY MANUFACTURER AND H6. HEALTH IMPACT, AND EVALUATION CODES: UPDATED. ONE USED DECONTAMINATED CUFF INFLATOR PRESSURE GAUGE AND ONE CUFF PRESSURE CONNECTING TUBE WERE RECEIVED IN SHELF CARTON. UNDER VISUAL INSPECTION THE SAMPLE APPEARED TO BE IN GOOD CONDITION. FUNCTIONAL TESTING FOUND THAT THE POINTER IS STACKED ON MAXIMUM POSITION. THE COMPLAINT WAS NOT CONFIRMED. THE CUFF INFLATOR IS A PURCHASED COMPONENT AND PER THE SUPPLIER THE READING ISSUE HAPPENS WHEN THE POINTER OF CUFF INFLATOR IS MISALIGNED (IN CONTACT WITH READING PLATE). THIS ISSUE IS CAUSED BY DROP OR HIT DAMAGE. THE MOST PROBABLE BUT UNCONFIRMED ROOT CAUSE WAS DUE TO DROP OR HIT DAMAGE, BUT IT WAS UNKNOWN WHERE AND WHEN THAT INCIDENT HAPPENED (MANUFACTURING/DISTRIBUTION/USE). A DEVICE HISTORY RECORD (DHR) REVIEW REPORTED NO DISCREPANCIES OR NON-CONFORMANCES DURING THE MANUFACTURING OF THE REPORTED LOT NUMBER. NO FURTHER ACTION WAS TAKEN.

Additional Manufacturer Narrative

OTHER, OTHER TEXT: UDI IN SECTION D4 AND G5 ARE UNKNOWN. NO INFORMATION HAS BEEN PROVIDED TO DATE. B3: DATE OF EVENT, NO INFORMATION HAS BEEN PROVIDED TO DATE. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN REQUIRED.

Description of Event or Problem

IT WAS REPORTED THAT THE CUFF WAS NOT MAINTAINING FULL INFLATION. IT WOULD NOT FULLY DEFLATE BUT DID NOT KEEP DESIRED INFLATION FULLNESS. NO PATIENT HARM WAS REPORTED.