|
Model Number IPN001112 |
Device Problem
Failure to Calibrate (2440)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/05/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).Other remarks: this report would not be likely to cause or contribute to a death or serious injury, and if it were to reoccur, it would be unlikely to cause or contribute to a death or serious injury.A fiber optic sensor (fos) not connecting cannot in itself cause or contribute to a patient death or serious injury.The fos is a portion of the catheter that monitors the patient's arterial pressure.When the fiber optic pressure signal is not available, the intra-aortic balloon (iab) is still able to be used since an arterial pressure signal is available through the central lumen.Iab therapy continues to the patient uninterrupted.
|
|
Event Description
|
It was reported that the staff got a cal key corrupt or missing error message when they were getting ready to insert a fiberoptic intra-aortic balloon (iab).The staff got the error message again after they disconnected and reconnected the fiberoptic connections on the intra-aortic balloon pump (iabp) that they were using.The staff got another iabp, made the fiberoptic connections and there was no error message and the iab was inserted into the patient and everything functioned appropriately.There was no report of patient complications, serious injury or death.
|
|
Event Description
|
It was reported that the staff got a cal key corrupt or missing error message when they were getting ready to insert a fiberoptic intra-aortic balloon (iab).The staff got the error message again after they disconnected and reconnected the fiberoptic connections on the intra-aortic balloon pump (iabp) that they were using.The staff got another iabp, made the fiberoptic connections and there was no error message and the iab was inserted into the patient and everything functioned appropriately.There was no report of patient complications, serious injury or death.
|
|
Manufacturer Narrative
|
(b)(4).Other remarks: this report would not be likely to cause or contribute to a death or serious injury, and if it were to reoccur, it would be unlikely to cause or contribute to a death or serious injury.A fiber optic sensor (fos) not connecting cannot in itself cause or contribute to a patient death or serious injury.The fos is a portion of the catheter that monitors the patient's arterial pressure.When the fiber optic pressure signal is not available, the intra-aortic balloon (iab) is still able to be used since an arterial pressure signal is available through the central lumen.Iab therapy continues to the patient uninterrupted.Corrected data: it was discovered that the defect reported by the customer is not a reportable event, thus the initial mdr sent on 03 mar 2021 should be retracted.
|
|
Search Alerts/Recalls
|
|
|