SMITHS MEDICAL ASD, INC. PNEUPAC® BABYPAC¿ VENTILATOR; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
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Model Number B100 |
Device Problems
Loss of Power (1475); No Flow (2991); No Pressure (2994)
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Patient Problem
Hypoventilation (1916)
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Event Date 03/20/2017 |
Event Type
Injury
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Manufacturer Narrative
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It was reported that the patient was a baby; however, the exact age is unknown.Customer has not returned the device to the manufacturer for device evaluation.If the devices becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
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Event Description
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It was reported that a pneupac® babypac¿ ventilator stopped working while in use on an airplane.The ventilator was connected on an oxygen cylinder that was full and connected to the airplane gas line.When the plane landed, there was a power loss, and no o2 was flowing through the device.Once the power returned, the ventilator did not work until the oxygen was disconnected and reconnected.The patient was manually ventilated.No permanent injury was reported.See mfr: 3012307300-2017-00949 and 3012307300-2017-00950.
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Manufacturer Narrative
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One device was returned for evaluation in used condition.Visual inspection of the ventilator did not identify any problem.It was observed that an old design exhalation valve was installed.Functional testing involved a simulated use test and showed that the reported issue was duplicated when input pressure was slowly increased.A leaking sound could be heard when the oxygen valve was slowly opened.It was identified that the oscillator dump valve was loose and the dump valve surface was rusted.Based on the evidence, it was shown that there was a pressure issue and the root cause was unknown.
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