Catalog Number IAP-0500 |
Device Problem
Device Displays Incorrect Message (2591)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/08/2016 |
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 via a field service report: (b)(4).Symptom: (pm)preventative maintenance due to high baseline alarm and system (3) error alarm.The iabp was on a patient but swapped quickly and did not harm patient.Findings / actions taken: found high baseline alarm then system (3) error alarm.Replaced p/s.Did not fix problem.Put old p/s back in.Replaced stepper motor controller did not fix problem.Reinstalled old stepper motor controller.Replaced pump assy fixing problem.Performed pm and functional check list.Iabp perform to spec.Fcn level: (b)(4).Software level: (b)(4).
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Manufacturer Narrative
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(b)(4) the pump assembly (p/n: 77-3200-001, s/n: (b)(4)) was returned for evaluation.Visual inspection of pump assembly was performed and found no obvious damage or defects.The pump assembly in question was installed into known good autocat2w and the functional testing was performed.When pumping was initiated the iabp alarmed with high baseline and then system error 3.Further evaluation of the pump assembly was performed and found the stepping motor to be faulty part.A known good stepper motor was installed into the pump assembly in question, and then installed in to known good autocat2w.The iabp passed the functional test.This is the original pump assembly of this 2005 iabp.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.Conclusion: the reported complaint of "unit alarmed high baseline and system error 3" is confirmed.The problem was duplicated during the functional test.The stepper motor of the pump assembly was found to be the cause of report problem.The root cause of the stepping motor malfunctioned cannot be determined.
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Event Description
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It was reported via a field service report: (b)(4).Symptom: (pm)preventative maintenance due to high baseline alarm and system (3) error alarm.The iabp was on a patient but swapped quickly and did not harm patient.Findings / actions taken: found high baseline alarm then system (3) error alarm.Replaced p/s.Did not fix problem.Put old p/s back in.Replaced stepper motor controller did not fix problem.Reinstalled old stepper motor controller.Replaced pump assy fixing problem.Performed pm and functional check list.Iabp perform to spec.Fcn level: 16.Software level: 2.24.
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Search Alerts/Recalls
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