Model Number IPN000320 |
Device Problem
Power Problem (3010)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/07/2022 |
Event Type
malfunction
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Event Description
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It was reported by the clinical support specialist (css) that the pump was alarming "on battery." the staff pressed the reset key and still had the alarm.The pump was pumping and supporting the patient.The staff tried changing the power cord; however, it did not resolve the issue.As a result, the staff changed the console, and the reported pump was sent to biomed.There was no report of patient complications, serious injury or death.
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Manufacturer Narrative
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(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.
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Event Description
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It was reported by the clinical support specialist (css) that the pump was alarming "on battery." the staff pressed the reset key and still had the alarm.The pump was pumping and supporting the patient.The staff tried changing the power cord.However, it did not resolve the issue.As a result, the staff changed the console, and the reported pump was sent to biomed.There was no report of patient complications, serious injury or death.
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Manufacturer Narrative
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(b)(4).No iabp part was returned to teleflex chelmsford for investigation.The reported complaint of "pump had the battery alarm while plugged in ac" is not able to be confirmed.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the lot number/serial number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risk.This will be monitored for any developing trends.
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Search Alerts/Recalls
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