PORTEX CUFF PRESSURE MONITORING

Additional Manufacturer Narrative

OTHER TEXT: D10. DEVICE AVAILABLE FOR EVALUATION; H3. DEVICE EVALUATED BY MANUFACTURER AND H6. EVALUATION CODES: UPDATED. ONE NON-DECONTAMINATED DEVICE WAS RECEIVED WITH ITS ORIGINAL PACKAGING. THE PRODUCT WAS PACKED IN THREE POLYBAGS. THE REPORTED STRONG SMELL WAS NOT NOTICED. THE COMPLAINT COULD NOT BE CONFIRMED. IT WAS NOTED THAT SMELL IS A VERY SUBJECTIVE ATTRIBUTE WHICH IS DIFFICULT TO PROPERLY EVALUATE. THE RETURNED PRODUCT HAD A COMMON ODOR IN COMPARISON WITH OTHER CUFF INFLATORS (RUBBER SMELL). A DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT PERFORMED AS NO DEVICE FAULT WAS FOUND. NO CORRECTIVE ACTIONS WERE TAKEN.

Description of Event or Problem

IT WAS REPORTED THAT DURING A PRE-USE CHECK THE PRODUCT WAS REPLACED WITH A NEW PRODUCT DUE TO A STRANGE SMELL, AND AFTER IT WAS STORED AT THE SALES OFFICE UNTIL THE SMELL WEAKENED, IT WAS DELIVERED. PATIENT INVOLVEMENT UNKNOWN.

Additional Manufacturer Narrative

B3: MONTH AND YEAR OF EVENT HAVE BEEN PROVIDED, DAY IS UNKNOWN. D4: UDI NUMBER IS UNKNOWN, NO INFORMATION HAS BEEN PROVIDED TO DATE. G5: 510K IS BLANK, DEVICE IS EXEMPT. 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.