Catalog Number 33-3025-001 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/09/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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There was no patient involvement.It was reported that the mforce was replaced.After the mforce was replaced, the intra-aortic balloon pump (iabp) had a system error 3 alarm when the iabp initiated pumping.
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Manufacturer Narrative
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(b)(4).Teleflex received the device for investigation.The reported complaint of "system error 3 alarm" is confirmed.During the investigation, the returned m-force was installed in a pump and alarmed for "system error 3".A broken connector pin on the motor driver/cpu cable of the m-force was noted and caused the alarms.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.A non-conformance has been initiated to further investigate the issue.
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Event Description
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There was no patient involvement.It was reported that the mforce was replaced.After the mforce was replaced, the intra-aortic balloon pump (iabp) had a system error 3 alarm when the iabp initiated pumping.
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Search Alerts/Recalls
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