[3592]
72 year old male fresh post-op developed difficulties shortly after the start of a platlet transfusion. The monitor on the patient went completley blank. No pressures or electrocardiographic tracings were visible. A portable monitor was brought in and it appeared that the patient's pressure had dropped and was continuing to drop. The patient's chest was opened and internal defibrillation was attempted. The defibrillator failed to fire. The patient was hooked up to another monitor and the monitor read "unrecognizable external device.? " no new types of equipment had been hooked up to the monitor. It was discovered by clinical engineering that there was something wrong with both the monitor and the defibrillator. The patient was taken ot surgery to evaluate the proble and to close his chest. It is the physician's opinion that the patient underwent unnecessary opening of the chest due to the malfunctioning of the equipment. Any service done to the equipment was done on a preventative maintenance schedule only. Device not labeled for single use. Patient medical status prior to event: critical condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. 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. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination. Results of evaluation: incorrect technique/procedure, defibrillator subassembly. Conclusion: device failure occurred and was related to event, device failure indirectly contributed to event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device permanently removed from service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5