HEMOSPHERE ALTA

Additional Manufacturer Narrative

ADDITIONAL PRODUCT CODE: DQE, DSB, DXN, FLL, MUD, QMS, QNL, DQK. ADDITIONAL FDA PREMARKET SUBMISSION: K242451. IT IS NOT KNOWN IF THE DEVICE WILL BE RETURNED. WITHOUT THE RETURN OF THE UNIT, IT IS NOT POSSIBLE TO DETERMINE IF SOME DAMAGE OR DEFECT EXISTED ON THE UNIT THAT COULD HAVE CONTRIBUTED TO THE EVENT. IT IS NOT KNOWN IF SOME PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. IN ADDITION, A DEVICE HISTORY RECORD CANNOT BE COMPLETED WITHOUT A SERIAL NUMBER. IF THE DEVICE IS RETURNED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS A PART OF THE MONTHLY REVIEW.

Description of Event or Problem

IT WAS REPORTED THAT, DURING USE, THE BLOOD PRESSURE (BP) READINGS OBTAINED FROM AN ALTA MONITOR WERE INCONSISTENT AND NOT CORRELATING WITH THE NON-INVASIVE BLOOD PRESSURE CUFF OR INVASIVE ARTERIAL LINE. MEAN ARTERIAL PRESSURE (MAP) VALUES, SYSTOLIC, AND DIASTOLIC VALUES WERE OFTEN VASTLY INACCURATE, EITHER MUCH HIGHER OR LOWER. PER REPRESENTATIVE, "THIS DISCREPANCY HAS OCCURRED REPEATEDLY SEVERAL TIMES PER DAY ACROSS MULTIPLE CASES AND APPEARS TO RESOLVE ONLY WHEN THE PATIENT MONITOR IS ZEROED BEFORE ACUMEN IQ FINGER CUFF APPLICATION." THERE WERE NO ALLEGATIONS OF PATIENT INJURIES. ISSUE OCCURRED AT OTHER HOSPITALS. FURTHER INFORMATION WAS NOT PROVIDED. IT IS UNKNOWN HOW MANY HOSPITALS AND MONITORS WERE AFFECTED.