PORTEX CUFF INFLATOR PRESSURE GAUGE

Additional Manufacturer Narrative

ONE USED SAMPLE WAS RECEIVED TO PERFORM AN INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORDS DHR) SHOWED THERE WERE NO OBSERVATIONS RECORDED DURING MANUFACTURE. A VISUAL INSPECTION NOTICED THAT ON DISPLAY THERE WAS DAMAGE ON ENTRANCE POINT. UPON INITIAL FUNCTIONAL TESTING IT WAS OBSERVED THAT POINTER OCCASIONALLY STACKED NEAR 25CMH2O. THIS IS A SUPPLIED ITEM WHICH HAS BEEN INVESTIGATED BY THE SUPPLIER WHO INDICATED THAT THIS IS NOT A MANUFACTURING ISSUE. THIS ISSUE HAPPENS WHEN THE POINTER OF A CUFF INFLATOR IS MISALIGNED (IN CONTACT WITH READING PLATE). THIS ISSUE IS CAUSED BY DROP OR HIT DAMAGE. IN ADDITION, PRODUCT IN THE MANUFACTURING AREA WAS INSPECTED ALONG WITH TRANSPORT TESTING AND NO PROBLEMS WERE DETECTED. THE MOST PROBABLE ROOT CAUSE FOR POINTER MISALIGNMENT AND INCORRECT MEASUREMENT IS HIT OR DROP DAMAGE CAUSED BY USER INTERFACE. THE ROOT CAUSE OF THE PROBLEM COULD NOT BE CONFIRMED. D4 UDI AND G5 ARE UNKNOWN. THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# (B)(4). THIS COMPLAINT IS PART OF A REMEDIATION REVIEW AND IS CONSIDERED A REPORTABLE EVENT.

Additional Manufacturer Narrative

THE FILE WAS INADVERTENTLY MARKED REPORTABLE. THE EVENT REPORTED UNDER MFR 3012307300-2020-07938 WAS DETERMINED TO BE NOT REPORTABLE AND NO FURTHER REPORTS WILL BE FILED USING THIS FILE NUMBER. THE HAZARDOUS SITUATION FOR THE GIVEN COMPLAINT DEVICE WOULD NOT LIKELY CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.

Description of Event or Problem

IT WAS REPORTED THAT THE PORTEX CUFF PRESSURE MONITOR EXHIBITED A FREQUENT FREEZING OF THE POINTER. THIS WAS COMPROMISING MEASUREMENTS. A PHOTOGRAPH PROVIDED BY THE CUSTOMER SHOWED THAT THE POINTER WAS STUCK AT THE ZERO MARK. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.