IN AN ABUNDANCE OF CAUTION, HILL-ROM IS REPORTING THE PATIENT DEATH AS THE PATIENT USED A HILL-ROM DEVICE IN THE HOURS PRECEDING HIS DEATH. HILL-ROM CONTACTED THE USER FACILITY MULTIPLE TIMES AND WAS UNABLE TO GET ANY ADDITIONAL INFORMATION RELATED TO THE DEVICE IDENTITY OR INCIDENT DETAILS. WE WERE UNABLE TO EVALUATE THE DEVICE INVOLVED IN THIS INCIDENT. THE MOST COMMON CAUSE OF SPLEEN RUPTURE IS SEVERE DIRECT BLUNT TRAUMA TO THE LEFT UPPER ABDOMEN OR THE LEFT LOWER CHEST. THE MECHANISM OF ACTION OF THE VEST IS NOT SUCH THAT IT PRODUCES FORCES EQUIVALENT TO SEVERE DIRECT BLUNT TRAUMA SO THE SPLEEN RUPTURE IS UNLIKELY ATTRIBUTED TO THE PERFORMANCE OF THE VEST. THERE WERE NO INDICATIONS OF A MALFUNCTION AS REPORTED BY THE FAMILY OR FACILITY. NO FURTHER INFORMATION IS AVAILABLE ON THIS INCIDENT OR DEVICE AT THIS TIME. A FOLLOW UP REPORT WILL BE SENT IF FURTHER INFORMATION BECOMES AVAILABLE.
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Patient 1
HILL-ROM RECEIVED A REPORT FROM THE PATIENT'S DAUGHTER STATING, "THE VEST THERAPY WAS FIRST PRESCRIBED AND PERFORMED ON (B)(6) 2016. PATIENT COMPLAINED OF THE THERAPY BEING PAINFUL AND STATED SO TO EITHER THE NURSE OF RESPIRATORY "NURSE". THE NURSE OR RESPIRATORY "NURSE" DID NOT STOP THE TREATMENT BUT MADE THE COMMENT THAT "THERE WAS ONLY 5 MINUTES LEFT OF THERAPY." OVER THE COURSE OF THE NEXT SEVERAL HOURS, THE PATIENT DID NOT FEEL WELL AND EVENTUALLY CODED AND EXPIRED APPROXIMATELY 12 HOURS AFTER THE COMPLETION OF THERAPY." THE DEVICE WAS AT (B)(6) HOSPITAL AT THE TIME OF THE REPORTED INCIDENT. THIS HAS BEEN FILED IN OUR COMPLAINT HANDLING SYSTEM AS (B)(4).