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Model Number IPN000320 |
Device Problem
Connection Problem (2900)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/18/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Qn#: (b)(4).
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Event Description
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There was no patient involvement, fault noted during equipment service.It was reported that a purge error occurred upon start-up of the intra-aortic balloon pump (iabp) , and was unable to hold a negative pressure.The field service engineer (fse) found the helium tank empty, and washer missing on adaptor.As a result, the fse replaced the pneumatic control system.
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Manufacturer Narrative
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(b)(4).Teleflex received the device for investigation.The reported complaint of "purge failure alarm" is confirmed.Upon return, the vent valve (v3) and the tip of inlet port fitting were damaged, which could result in the reported alarm.The potential cause of the damage is customer handling, suspected to have occurred during pump service/repair.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 revived risk.This will be monitored for any developing trends.
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Event Description
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There was no patient involvement, fault noted during equipment service.It was reported that a purge error occurred upon start-up of the intra-aortic balloon pump (iabp) and was unable to hold a negative pressure.The field service engineer (fse) found the helium tank empty and washer missing on adaptor.As a result, the fse replaced the pneumatic control system.
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Search Alerts/Recalls
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