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Model Number IPN917285 |
Device Problems
Failure to Run on Battery (1466); Complete Loss of Power (4015)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/18/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Other remarks: n/a.Corrected data: n/a.
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Event Description
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It was reported that while on battery power during use on a patient transporting from the ccu to ct and back to the ccu, the battery failed and the pump suffered a complete loss of power.As a result, the pump was exchanged for another pump.No patient harm or injury.The initial pump had been plugged into ac power, per ifu.When unplugged, the pump immediately and inaccurately displayed "battery life less than " 20 min, 10 min, and 5 min in a row within seconds.The pump did not last on battery power per the indicated time left.The patient status was reported as "critical" prior to the pump battery failure.Patient condition unchanged by event.
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Manufacturer Narrative
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(b)(4).No iabp part was returned to teleflex chelmsford for investigation.According to the field service report, a field service engineer confirmed the reported issue.As a result, the battery was replaced.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.The reported complaint of "battery failure" was confirmed by the field service engineer.No part was returned to teleflex chelmsford for investigation.The battery was replaced by the field service engineer.Based on a review of the device history record (dhr), the product met specification upon release; however, the specifications were not met during the complaint investigation due to the battery failure.The root cause of the complaint is undetermined.No further action required at this time.The reported complaint 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.
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Event Description
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It was reported that while on battery power during use on a patient transporting from the ccu to ct and back to the ccu, the battery failed and the pump suffered a complete loss of power.As a result, the pump was exchanged for another pump.No patient harm or injury.The initial pump had been plugged into ac power, per ifu.When unplugged, the pump immediately and inaccurately displayed "battery life less than " 20 min, 10 min, and 5 min in a row within seconds.The pump did not last on battery power per the indicated time left.The patient status was reported as "critical" prior to the pump battery failure.Patient condition unchanged by event.
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Search Alerts/Recalls
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