Model Number 21-7302-24 |
Device Problems
Device Alarm System (1012); Pressure Problem (3012)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/03/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
No product was returned.We are unable to confirm the reported complaint.If the product is returned, smiths medical will reopen this complaint for further investigation a supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
|
|
Event Description
|
It was reported the disposable caused the pump to alarm high pressure during the night.No further details provided.No injury reported.
|
|
Manufacturer Narrative
|
Other, other text: a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.
|
|
Search Alerts/Recalls
|