[3410]
The above mentioned ventilator was in use in icu bed 3 on patient. The respiratory technician stated that the ventilator made a loud "whining" noise that seemed to increase/decrease as the peep was adjusted. She also stated that the compressor was running although the ventilator was plugged into the hospital air supply. The ventilator settings were set as per the ventilatro flowsheet (attached). At approximately 3:50 p. M. , the ventilator alarmed, went into "vent inop" mode, and shut down. Upon my arrival, the ventilator was outside the room and another ventilator was in the process of being set up. The ventilator ce #1981) was brought to the clinical engineering department for evaluation. Upon initial evaluation, i found the main circuit breaker tripped. This is what put the ventilator into "vent inop". I also found the air inlet filter dirty, which caused a drop in air flow to the ventilator, which in turn caused the compressor to turn on. The unit only has 1500 hours on it since overhaul, but completed ventilator and compressor p. M. Anyway. During the p. M. , the compressor output was found to be 10 p. S. I. (no flow). It was adjusted to 11. 2 p. S. I. And monitored for stability. The amperage a. C. Plug were loose in their terminals-they were reterminated and tightened. There was no evidence of water contamination to the ventilator. The p. M. Was performed per manufacturers recommendations. The ventilator was then run inthe shop for two full days (16 hrs) at standard settings and stress settings-no failures occured. After this time, an operational verification procedure was performed. The ventilator passed all of the verifications. The unit was then returned to servicedevice not labeled for single use. Patient medical status prior to event: fair condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-aug-92. Service provided by: manufacturer. Service records available. 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, performance tests performed. Results of evaluation: foreign material contamination, other. Conclusion: device failure occurred and was related to event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device repaired and put back in service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5