Catalog Number IAP-0400 |
Device Problem
Mechanical Problem (1384)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 05/16/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).There is an investigation ongoing into this reported complaint.A supplement follow-up mdr report will be submitted with the investigation results upon completion of the investigation.
|
|
Event Description
|
It was reported that the pump suddenly failed to start during used on a patient.The alarm system error 3 repeatedly occurred after the machine ran for a short time.As a result, the pump was replaced with another pump.There was no report of patient complications, serious injury, or death.
|
|
Manufacturer Narrative
|
(b)(4).The reported complaint of system error 3 alarm is not able to be confirmed.The product was not returned for investigation.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint is undetermined.No further action required at this time.The reported complaint will be monitored for any developing trends.
|
|
Event Description
|
It was reported that the pump suddenly failed to start during used on a patient.The alarm system error 3 repeatedly occurred after the machine ran for a short time.As a result, the pump was replaced with another pump.There was no report of patient complications, serious injury, or death.
|
|
Search Alerts/Recalls
|