PORTEX CUFF PRESSURE MONITORING

Description of Event or Problem

IT WAS REPORTED THAT THE CLOCK DID NOT RESPOND TO THE BULB BEING PRESSED, MAKING IT IMPOSSIBLE TO MEASURE THE PRESSURE. THE REPORTED PRODUCT WAS IN USE ON A PATIENT, AND THE PROBLEM WITH THE CUFF WAS OBSERVED WHEN THEY WENT TO MEASURE THE CUFF. IN ADDITION, IT WAS STATED THAT THE PROBLEM DID NOT CAUSE OR CONTRIBUTE ANY INJURIES OR HARM TO THE PATIENT.

Additional Manufacturer Narrative

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 INFORMATION BECOMES AVAILABLE.

Additional Manufacturer Narrative

D3 - MFG ESTABLISHMENT NAME AND ADDRESS: CORRECTED. D9 - DATE RETURNED TO MFG: 10/16/2025. H3 AND H6 CODES - UPDATED. ONE USED UNIT WAS RETURNED FOR INVESTIGATION. THE DEVICE WAS VISUALLY INSPECTED AND THE CUSTOMER REPORTED ISSUE WAS CONFIRMED. AS PER RESULTS FROM SUPPLIER INVESTIGATION THIS ISSUE HAPPENS AFTER MANUFACTURING BECAUSE EACH PRODUCT IS TESTED ON FUNCTION BY MANUFACTURER. THE READING ISSUE HAPPENS WHEN POINTER OF CUFF INFLATOR IS MISALIGNED IN CONTACT WITH READING PLATE. THE CUSTOMER REPORTED ISSUE HAD HAPPENED MOST PROBABLY DUE TO DROP OR HIT DAMAGE AND THE CAUSE WAS UNKNOWN.

Additional Manufacturer Narrative

ONE VIDEO WAS PROVIDED FOR EVALUATION OF THE REPORTED ISSUE AND CONFIRMED THAT THE POINTER IS STACKED AND DOES NOT MOVE. THE REPORTED PRODUCT FAILURE THE PROBABLY HAPPENED DUE TO DROP OR HIT DAMAGE DURING USE BUT IT CANNOT BE PROVED WITH CERTAINTY THEREFORE ROOT CAUSE OF THIS COMPLAINT REMAINS UNKNOWN. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWS THERE WERE NO OBSERVATIONS RECORDED DURING MANUFACTURE TO SUGGEST AN ISSUE OF THIS NATURE WOULD OCCUR WITH THIS LOT OF PRODUCTS.