PORTEX CUFF PRESSURE MONITORING
Received Apr 6, 2023 · Event occurred Feb 1, 2023
Report 3012307300-2023-03683 · MDR key 16693300
Device
Generic name
Cuff Inflator Pressure Gauge
Manufacturer
Smiths Medical International, Ltd.Catalog number
100/568/000
Lot number
4178689
Product problems
- Display or Visual Feedback Problem
- Output Problem
- Display or Visual Feedback Problem
- Output Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
OTHER TEXT: H3. DEVICE EVALUATED BY MANUFACTURER AND EVENT PROBLEM AND EVALUATION CODES: UPDATED. ONE USED DECONTAMINATED SAMPLE WAS RETURNED WITH ITS ORIGINAL PACKAGING. UNDER VISUAL INSPECTION THE SAMPLE APPEARED TO BE IN GOOD CONDITION. OUTLET NOZZLE WAS OCCLUDED BY FINGER AND CUFF INFLATOR WAS INFLATED FROM ZERO TO MAXIMUM SEVERAL TIMES. NO ABNORMALITIES WERE OBSERVED; POINTER WAS SMOOTHLY MOVING ACROSS WHOLE MEASURING RANGE. BASED ON FUNCTIONAL TESTING THE COMPLAINT WAS NOT CONFIRMED. THERE HAVE BEEN NO REPORTS OF SIMILAR COMPLAINTS GOING BACK TWO YEARS. A DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT PERFORMED AS NO FAULT WAS FOUND.
Additional Manufacturer Narrative
DATE OF EVENT: MONTH AND YEAR OF EVENT HAVE BEEN PROVIDED, DAY IS UNKNOWN. UDI NUMBER IS UNKNOWN, NO INFORMATION HAS BEEN PROVIDED TO DATE. 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.
Description of Event or Problem
IT WAS REPORTED THAT DURING THE USE OF THE PRODUCT, THE CUSTOMER NOTICED THE INDICATOR NEEDLE WOULD NOT MOVE SMOOTHLY. NO PATIENT INJURY WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS COMPLAINT.