Catalog Number IAP-0500 |
Device Problem
Erratic or Intermittent Display (1182)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/15/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).No components returned to the manufacturer.
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Event Description
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It was reported via a hot line call.The biomed technician is calling with a pump in the biomed shop that was sent from the intensive care unit (icu) after the screen had "flashed" and "the numbers were jumping erratically up and down", as reported to him from the nurse.The biomed tech did not have any other information besides that.The clinical support specialist (css) first verified that there were no issues related to the patient that was on this pump.The css had the biomed tech check the monitor cord connections, but they all seemed to be well attached.The css then informed him that he is the clinical on call, and that he would forward his information on to field service.On (b)(6) 2016 another hot line call was received.The biomed is calling to further discuss the pump reported with the erratic pressure readings from the previous call.The biomed explained that the pump was sent to biomed with the report of erratic pressure readings and that they had to put the pump in operator mode and set timing themselves and change to the transducer for ap signal.In v-pace, they reported to the biomed that they had timing set at 37-86% but received insufficient time to inflate/deflate (specifics are minimal).Unknown what the patient rhythm was.They changed pumps (changed to sn (b)(4) and then used peak trigger with timing set at 50-85% still in operator mode.The biomed had no further details/information.
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Manufacturer Narrative
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Qn#(b)(4).No parts or recorder strips were returned to the teleflex (b)(4) facility for evaluation.The wws database was also checked and there was no further service provided to the pump related to the reported call report per support services, this account is a demand customer (no service contract).They perform their own repairs.No further information received from the customer at this time.A device history record (dhr) review was conducted for the iap lot/serial numbers with no relevant findings.The devices passed all manufacturing specifications prior to release.Conclusion: the reported complaint of the screen had "flashed" and "the numbers were jumping erratically up and down" is not confirmed.This account is a demand customer account (no service contract).The world wide service database was also checked and there was no further service provided to the pump related to the reported call report.No iabp parts or recorder strips were returned to teleflex (b)(4) for evaluation.The cause of the reported complaint is undetermined.
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Event Description
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It was reported via a hot line call.The biomed technician is calling with a pump in the biomed shop that was sent from the intensive care unit (icu) after the screen had "flashed" and "the numbers were jumping erratically up and down", as reported to him from the nurse.The biomed tech did not have any other information besides that.The clinical support specialist (css) first verified that there were no issues related to the patient that was on this pump.The css had the biomed tech check the monitor cord connections, but they all seemed to be well attached.The css then informed him that he is the clinical on call, and that he would forward his information on to field service.On 10/17/2016: another hot line call was received.The biomed is calling to further discuss the pump reported with the erratic pressure readings from the previous call.The biomed explained that the pump was sent to biomed with the report of erratic pressure readings and that they had to put the pump in operator mode and set timing themselves and change to the transducer for ap signal.In v-pace, they reported to the biomed that they had timing set at 37-86% but received insufficient time to inflate/deflate (specifics are minimal).Unknown what the patient rhythm was.They changed pumps (changed to sn (b)(4)) and then used peak trigger with timing set at 50-85% still in operator mode.The biomed had no further details/information.
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Search Alerts/Recalls
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