Udi updated - (b)(4).Evaluation codes updated.Device evaluation: one device was received.A visual inspection found a stuck gas supply indicator, the eyeball was dislodged from the assembly, the housing contained impact marks on the bottom and around the battery compartment, all 3 small knobs were missing and the manometer needle was out of spec.During the functional testing, it was confirmed that the gas supply indicator was stuck and did not move.It was determined that the cause was from an impact to the device.The damaged gas supply indicator set was replaced as well as the mri battery, sintered filter, o'rings, gas supply indicator set, missing control knobs and end caps and the pressure manometer.Service history review identified there was no indication that the complaint was related to a service of the device within the review period.Product is beyond a year from manufacture date and there was no indication of a manufacturing defect during the investigation, so a dhr review was not performed.For all enquiries or follow-up questions related to the record, do not use (b)(6) located in, please direct those to the following: (b)(6).
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