SMITHS MEDICAL ASD, INC. MEDEX TRANSTAR PRESSURE MONITORING SYSTEM; PROBE, BLOOD-FLOW, EXTRAVASCULAR
|
Back to Search Results |
|
Model Number MX9505T |
Device Problems
Crack (1135); Leak/Splash (1354)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 08/26/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.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.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
|
|
Event Description
|
It was reported that the drainage nurse found that the pressure sensor connector is cracked and drain leakage.After replacement of new pressure sensors, the product was working normal.No patient injury was reported.
|
|
Search Alerts/Recalls
|
|
|