Description of Event or Problem · 1
ON 3/5/93 AT APPROXIMTELY 1:15 A.M. THIS 72 YEAR OLD VENTILATOR DEPENDANT FEMALE, S/P LEFT CVA, WAS FOUND WITH HER TRACHEOSTOMY TUBE OUT OF HER NECK STILL CONNECTED TO THE CENTILATOR TUBING. SHE WAS NOTED TO BE UNRESPONSIVE WITH NO PULSE OR BLOOD PRESSURE. A CARDIAC ARREST WAS CALLED AND THE PATIENT SUCCESSFULLY RESUSCITATED. HOWEVER, POST ARREST SHE HAD EVIDENCE OF ANOXIC BRAIN INJURY. SHE EXPIRED ON 3/12/93.ACCORDING TO THE STAFF CARING FOR THE PATIENT, THE VENTILATOR ALARMS DID NOT SOUND WHEN THE TRACHEOSTOMY TUBE BECAME DISLODGED. THE VENTILATOR WAS REMOVED FROM SERVICE UNTIL THIS ISSUE COULD BE EVALUATED. ON 3/17/93 THE MANUFACTURER BEAR MEDICAL SYSTEM INC. ("BEAR"), WAS CONTACTED AND INFORMED THAT THERE MAY HAVE BEEN A VENTILATOR MALFUNCTION. BEAR WAS INVITED TO SEND A REPRESENTATIVE TO PERFORMED THE OVP WHICH REVEALED THAT THE VENTILATOR MET ALL MANUFACTURER SPECIFICATIONS.IN ADDITION TO THE OVP PERFORMED BY BEAR, THE HOSPITAL RETAINED AN INDEPENDENT BIOMEDICAL ENGINEERING ORGANIZATION TO CONDUCT AN EVALUATION OF THE EVENT. THIS EVALUATION REVEALED THAT THE VENTILATOR'S LOW EXHALED VOLUME ALARM CONTROL IS CAPABLE OF BEING FULLY DISABLED WHEN SET AN INCREMENTAL DISTANCE FROM THE 0.1 LITER ALARM THRESHOLD, WHICH HAD BEEN RECORDED ON THE PATIENT'S VENTILATOR RECORD. NO INDICATION IS PROVIDED BY THE VENTILATOR THAT THIS ALARM IS DISABLED.IN ADDITION, IT APPEARS THAT THE VENTILATOR'S LOW-PRESSURE AND APNEA ALARMS ALSO FAILED TO ACTIVATE UPON DISCONNECTION OF THE BREATHING CIRCUIT. ACCORDING TO THE VENTILATION RECORD, THE LOW PRESSURE ALARM HAD BEEN SET AT 5CM OF H2O. UPON DISCONNECTION OF THE BREATHING CIRCUIT, CONTACT OF THE CIRCUIT WITH THE BED LINENS CAUSED ENOUGH BACK PRESSURE IN THE CIRCUIT TO MEET THE 5CM OF WATER PRESSURE THRESHOLD THEREBY PREVENTION OF THE LOW PRESSURE AND APNEA ALARMS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.