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Catalog Number IAP-0400 |
Device Problem
Failure to Run on Battery (1466)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/05/2023 |
Event Type
malfunction
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Event Description
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It was reported that during use on a patient, "the pump keeps ringing and cannot work in the early morning.According to the engineer's guidance, turn off the battery switch and restore the pump to normal.After 10 minutes, the device reappeared with a black screen and a long beep alarm, making it unable to function.The engineer determined that there was a problem with the battery module".The issue was resolved but exchanging the pump for another.No patient harm or injury.No medical intervention necessary.Per the customer, the patient status is reported as "unknown".
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Manufacturer Narrative
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(b)(4) other remarks: n/a.Corrected data: n/a.
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Manufacturer Narrative
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Qn# (b)(4).The reported complaint of "black screen and a long beep alarm" is not able to be confirmed.The product was not returned for investigation.According to the event details, the battery issue was resolved by charging the battery.Based on a review of the device history record (dhr), the product met specification upon release.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.Teleflex will continue to monitor and trend on complaints of this nature.Other remarks: n/a.Corrected data: n/a.
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Event Description
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It was reported that during use on a patient, "the pump keeps ringing and cannot work in the early morning.According to the engineer's guidance, turn off the battery switch and restore the pump to normal.After 10 minutes, the device reappeared with a black screen and a long beep alarm, making it unable to function.The engineer determined that there was a problem with the battery module".The issue was resolved but exchanging the pump for another.No patient harm or injury.No medical intervention necessary.Per the customer, the patient status is reported as "unknown".
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Search Alerts/Recalls
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