It was reported that while inflating the cuff on the patient's trach, they were unable to inflate the cuff and found the cuff to be ?blown".The event occurred on the critical care floor.No adverse patient effects were reported by the customer.Customer reported: "there was no medical intervention, there was no patient harm".A1: one patient, two product malfunctions.(b)(6) represent the same patient.
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Other, other text: no device was returned for investigation therefore, the complaint could not be confirmed.A device history record (dhr) review showed no non-conformances or discrepancies during the manufacturing of the reported lot number.If the device is returned the manufacturer will re-open the complaint for further device analysis.
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