Catalog Number IAP-0500 |
Device Problems
No Display/Image (1183); Pumping Stopped (1503)
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Patient Problem
Myocardial Infarction (1969)
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Event Date 02/25/2016 |
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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It was reported that the rn from the cath lab was calling to report that the intra-aortic balloon pump (iabp) had a "main cpu failure" last night.The rn stated that "at start-up of pump" the screen went blank and the pump powered down.They replaced the pump with another and were able to continue with the procedure with no further issues.The clinical support specialist (css) first verified that they were able to support the patient with a different pump and that there was only a minimal delay of "about two minutes" to replace the pump.The css then asked if they had tried to power the original pump back on since the incident and the rn stated that they did successfully power it on.The css recommended that they have the original pump checked by biomed prior to returning it to service.
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Manufacturer Narrative
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(b)(4) device evaluation: the cpu (central processing unit) board was returned for evaluation.Visual inspection of the cpu board was performed and no abnormalities were found.The cpu board in question was installed onto the cpu/fe/fos board test fixture and the functional test was performed.No faults were found.The cpu board passed testing.The cpu board was then installed into a known good intra-aortic balloon pump ((b)(4)) and functional testing was performed.The pump was powered up successfully without any issues.The pump with cpu board in question passed all functional testing.The pump was then left to run for six hours and no alarms or errors occurred.No device history record required.No problem found on the returned sample.Conclusion: the reported complaint of "display screen went blank" is not confirmed.The reported problem could not be replicated at teleflex (b)(4) facility during the functional test.The cause of reported alarm is undetermined.
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Event Description
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It was reported that the rn from the cath lab was calling to report that the intra-aortic balloon pump (iabp) had a "main cpu failure" last night.The rn stated that "at start-up of pump" the screen went blank and the pump powered down.They replaced the pump with another and were able to continue with the procedure with no further issues.The clinical support specialist (css) first verified that they were able to support the patient with a different pump and that there was only a minimal delay of "about two minutes" to replace the pump.The css then asked if they had tried to power the original pump back on since the incident and the rn stated that they did successfully power it on.The css recommended that they have the original pump checked by biomed prior to returning it to service.
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Search Alerts/Recalls
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