|
Model Number MX9505T |
Device Problems
Leak/Splash (1354); Connection Problem (2900)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 06/18/2020 |
Event Type
malfunction
|
Event Description
|
It was reported that when drawing blood from the patient, the extension tube at the lower end of the 3-way switch at the pressure sensor and the transducer was observed to not be tightly connected and easy to fall off.No patient injury was reported.
|
|
Manufacturer Narrative
|
This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.
|
|
Search Alerts/Recalls
|
|
|