Model Number 900076 |
Device Problems
Partial Blockage (1065); Output Problem (3005)
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Patient Problem
Insufficient Information (4580)
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Event Date 04/12/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Coopersurgical, inc.Is currently investigating the reported condition.
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Event Description
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Will not spray confirmed complaint: partial blockage in main valve.Bad relief device seal.Cleared blockage and replaced relief device seal.Repair order (b)(4).1216677-2022-00130 wallach ultra freeze 900076 e-complaint-(b)(4).
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Manufacturer Narrative
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Investigation.Review dhr.Inspect returned samples.Analysis and findings complaint (b)(4).Distribution history: this complaint unit was manufactured at csi on 12/22/2016 under wo #(b)(4) and shipped on 01/06/2017.Manufacturing record review: dhr 195185 was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: not applicable.Service history record: this unit was serviced in 2017 for a main valve replacement.Historical complaint review: a review of the 2-year complaint history showed similar reported complaint condition.Product receipt: the complaint unit was returned on a repair.Visual evaluation: visual examination of the complaint unit revealed no physical damage.Functional evaluation: complaint unit was functionally evaluated and found not to function properly.Service & repair confirmed the complaint unit's relief valve had a bad seal and there was a blockage in the main valve.Root cause: blockage in the main valve indicates the liquid nitrogen source was not clean coming from the dewar.Root cause is being attributed to handling and wear & tear.Corrective actions the unit was repaired, tested and returned to the customer.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary.No further training required.*was the complaint confirmed? yes.
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Event Description
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Will not spray.Confirmed complaint: partial blockage in main valve.Bad relief device seal.Cleared blockage and replaced relief device seal.Repair order (b)(4).1216677-2022-00130-1 wallach ultra freeze 900076 e-complaint(b)(4).
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Search Alerts/Recalls
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