H6: event problem and evaluation codes: updated.H10: device evaluation: visual inspection of the two returned devices did not identify any defects.The devices were leak tested per work instruction, wi-10-012 rev112.No leaks were detected.The cuffs were inflated with 10 cc of water and the various portions of the inflation system were manipulated.No leaks were detected.The devices with 10 cc of water in the cuffs were allowed to rest several days.No leaks were evident while the device was resting.Using a syringe, the water was evacuated.Approximately 10 cc of water was removed, the minor difference is accounted for the small amount of water that remains in the inflation system.Based on the limited information in the complaint description, it is unknown what the caregiver used to inflate the cuffs, but using air would account for the nightly loss in volume.The reported problem could not be confirmed.No corrective actions are planned at this time.There were no non-conforming reports (ncrs) initiated for the lots or anomalies identified in the dhrs.
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