VYAIRE MEDICAL OY VITAL SIGNS¿ FETAL SPIRAL ELECTRODE CABLE FOR COROMETRICS¿, RECTANGULAR CONNECTO; CABLE, ELECTRODE
|
Back to Search Results |
|
Model Number CABLE, FETAL SCALP ELECTRODE, RECTANGLE |
Device Problem
Disconnection (1171)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/16/2023 |
Event Type
malfunction
|
Event Description
|
The customer reported that the leg attachment pad would not stay connected to the cable.The nurse will push down and pinch it, and it will transmit properly, but when they let go, it creates an artifact, and the fetal heart rate cannot be traced.The customer confirmed that there was no patient harm associated with the reported event.
|
|
Manufacturer Narrative
|
H3: 81 other - at this time, the suspect device has not been returned for evaluation.No root cause has been determined yet.On follow-up, the customer confirmed that the sample was thrown away after patient use.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.H3 other text : product discarded.
|
|
Search Alerts/Recalls
|
|
|