Model Number IPN000325 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/02/2021 |
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 during product training/demonstration, the alarm of system error 3 went off after pumping started.The user tried to restart the pumping by turning off and on the main power switch; however, the same alarm went off immediately.The alarm went off about 5 times in the end.A technical specialist is scheduled to visit the facility for inspection of the intra-aortic balloon pump (iabp).
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Manufacturer Narrative
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Qn#(b)(4).Teleflex received the device for investigation.The reported complaint of "system error 3 alarm" is confirmed.A loose connector pin on the output cable of the m-force was noted and caused the alarms.The root cause of the complaint is undetermined.A non-conformance has been initiated to further investigate the issue.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.
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Event Description
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There was no patient involvement.It was reported that during product training/demonstration, the alarm of system error 3 went off after pumping started.The user tried to restart the pumping by turning off and on the main power switch; however, the same alarm went off immediately.The alarm went off about 5 times in the end.A technical specialist is scheduled to visit the facility for inspection of the intra-aortic balloon pump (iabp).
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Search Alerts/Recalls
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