Catalog Number IAP-0500 |
Device Problems
Low Battery (2584); Battery Problem (2885)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/21/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Other remarks: user facility report #: (b)(4).
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Event Description
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It was reported via a user facility report that while the patient was being transported through the emergency room to the patient's room the balloon pump shut down during transport.There was no battery life at all.The pump was continuously plugged in prior to the transport.The patient was not affected and the blood pressure remained stable.The patient was hooked up to receiving hospital's intra-aortic balloon pump (iabp).
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Manufacturer Narrative
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(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of "the pump stop pumping" cannot be confirmed.Although, the root cause of the reported complaint is undetermined the hospital biomed serviced the pump and the battery was replaced.This complaint will be monitored for any developing trends.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.No further action required at this time.Other remarks: user facility report #: (b)(4).
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Event Description
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It was reported via a user facility report that while the patient was being transported through the emergency room to the patient's room the balloon pump shut down during transport.There was no battery life at all.The pump was continuously plugged in prior to the transport.The patient was not affected and the blood pressure remained stable.The patient was hooked up to receiving hospital's intra-aortic balloon pump (iabp).
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Search Alerts/Recalls
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