Other, other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter (b)(4).D3 manufacturer name: supplier: simcol medical d.O.O.D4 (udi), g2 and g5 are unknown; no further information has been provided.This is a supplied item.A device history record (dhr) review was not applicable in this case because the component is not evaluated or tested in any way during the manufacturing process at this manufacturer; and the device manufacturing records are retained by the supplier at their manufacturing site and are not readily available for review.Cables and connector were returned in used condition.Only visual inspection of cable and connector was performed: one cable has a crack in the outer insulation.There was no external damage visible on the remaining 7 cables.The reported problems could not be tested due to missing test equipment.Due to the absence of test equipment, the fault cannot be verified.
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