It was reported that the connecting screw between the red 3-way stopcock and the blue 3-way stopcock loosens again by itself during operation.This is first noticeable by falling blood pressure values, only late then the measurement stops completely.Then, of course, the puddle formation on the floor is noticeable.Additionally it was reported that disconnection was at a connection point without external influence.
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Other, other text: h6: event problem and evaluation codes: updated.H10: device evaluation was completed.No product was returned for investigation.Pictures received do not show the described defect.The cause of the reported problem could not be determined.A dhr (device history review) was performed and no problems or issues were identified during this dhr review.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 if additional reportable information becomes available., corrected data: e4: correction: customer reported to fda: no information.
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