Description of Event or Problem · 1
THE MACHINE WAS ATTACHED TO THE PRESSURE SOURCE-COMPRESSED NITROGEN. THE PRESSURE WAS TURNED ON. THE NURSE WAS AWARE THAT THE MACHINE OPERATES ON A PRESSURE OF 70-80 PSI AND THE PRESSURE WAS BEING TURNED TO ZERO WHEN THERE WAS A POP SOUND FROM THE MACHINE. THE MACHINE WAS NOT TURNED ON, NOR WAS THE DISPOSABLE TUBING (STERILE) CONNECTED AND THEREFORE NOTHING WAS IN CONTACT WITH THE PT.DEVICE NOT LABELED FOR SINGLE USE. 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.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. 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.