Model Number IPN000320 |
Device Problem
Communication or Transmission Problem (2896)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/22/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Qn# (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 that the staff was receiving inappropriate triggering and late deflation timing while the pump was on autopilot.As a result, the console, leads, and electrodes were exchanged.There was no report of patient complications, serious injury or death.
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Event Description
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It was reported that the staff was receiving inappropriate triggering and late deflation timing while the pump was on autopilot.As a result, the console, leads, and electrodes were exchanged.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 inappropriate triggering is confirmed based on the photos and videos submitted with the complaint.The root cause of this 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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