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Catalog Number IAP-0700 |
Device Problems
No Display/Image (1183); Application Program Freezes, Becomes Nonfunctional (4031)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/21/2019 |
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 touchscreen on the intra-aortic balloon pump (iabp) has been non-responsive the entire time that the pump has been on this patient in the cardiac intensive care unit (icu).The hard keys are still working, and they have been able to do their normal tasks without using the touchscreen.As a result, the pump was switched out for another iabp.There have been no delays in therapy at all, and no harm to the patient.There was no report of patient injury or consequence.
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Manufacturer Narrative
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(b)(4).Teleflex received the device for investigation.The reported complaint of iabp touch screen unresponsive is confirmed based on the photos provided in the complaint of recorder strips showing system error 7 alarms; however, the returned display head passed visual and functional test specifications.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.This will be monitored for any developing trends.No further action required at this time.
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Event Description
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It was reported that the touchscreen on the intra-aortic balloon pump (iabp) has been non-responsive the entire time that the pump has been on this patient in the cardiac intensive care unit (icu).The hard keys are still working, and they have been able to do their normal tasks without using the touchscreen.As a result, the pump was switched out for another iabp.There have been no delays in therapy at all, and no harm to the patient.There was no report of patient injury or consequence.
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Search Alerts/Recalls
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