The reported issue was inconclusive.The root cause of the reported issue could not be determined.A potential root cause is temperature cable failure.However this cannot be confirmed.Nurse verified that the foley probe was in place.Nurse denied bladder flushes and verified patient temperature was via bedside monitor.Mss advised to make sure temperature connector was attached securely to the device and the probe.Mss advised to flex cable or disconnect and reconnect the cable.Mss advised to contact biomed to see if they had a cable available.Nurse would call back if this does not resolve.All good faith attempts have been made to obtain additional information.The outcome of the repair cannot be determined at this time.In the event that information regarding the outcome of the repair and the status of the device is received, this record will be reopened to update the investigation.The lot number was unknown; therefore, the device history record could not be reviewed.Unable to perform labeling review due to unknown product code.Although the product family was unknown, the (temperature cable) product ifus were found to be adequate based on past reviews.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.
|