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Model Number IPN001112 |
Device Problem
Power Problem (3010)
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Patient Problem
Insufficient Information (4580)
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Event Date 05/06/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).There is an investigation ongoing into this reported complaint.A supplement follow-up mdr report will be submitted with the investigation results upon completion of the investigation.
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Event Description
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It was reported by the clinical support specialist (css) that the pump "shut down when it went over a bump." there is currently no additional information on the event, and if additional information is received at a later date, the complaint will be updated accordingly.There was no report of patient complication, serious injury, or death.
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Event Description
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It was reported by the clinical support specialist (css) that the pump "shut down when it went over a bump." there is currently no additional information on the event, and if additional information is received at a later date, the complaint will be updated accordingly.There was no report of patient complication, serious injury, or death.
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Manufacturer Narrative
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Qn#(b)(4).A battery was returned for investigation.The battery was installed into a known good ac3 for functional testing.The iabp powered up successfully with no alarm, all voltages were present (+5v, +12v and -12v) and within specifications.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.The reported complaint of "shut down when it went over a bump" is not able to be confirmed; however, the returned battery failed battery load test during complaint investigation.The pump shut off approximately 38 minutes when operating on battery power after a full charge.Based on a review of the device history record (dhr), the product met specification upon release; however, the received product did not meet test specifications during the complaint investigation due to the short battery run time.A definitive root cause could not be determined but a potential cause of the short battery life is a result of maintaining of the battery.No further action required at this time.This will be monitored for any developing trends.Iabp users and servicers must follow the operating instructions manual for recommendations on usage, charging, maintenance and storage of the batteries.If battery maintenance is not performed per the iabp operating instructions manual, the battery may not provide the expected minimum run time of operating power.Teleflex chelmsford will continue to monitor and trend for reports of this nature.
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Search Alerts/Recalls
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