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Model Number IPN000320 |
Device Problem
Charging Problem (2892)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/03/2021 |
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 machine is not getting switched on and not responding to on switch while on." it was noted that it was "starting with 5v piezo alarm tone." as a result, a new pump was used.There was no report of patient complication or serious injury and death.
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Manufacturer Narrative
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Qn# (b)(4).Teleflex received the device for investigation.The reported complaint of "unit failed to power-on with piezo alarm" is confirmed.The power supply was found to be unable to charge the battery, during testing.A definitive root cause is undetermined.However, a potential cause is the unit operating outside the environmental control.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.Teleflex assessed, the risk for the reported complaint.There are no new or revised risk.This will be monitored for any developing trends.
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Event Description
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It was reported, that "the machine is not getting switched on.And not responding to on switch, while on".It was noted, that it was "starting with 5v piezo alarm tone".As a result, a new pump was used.There was no report of patient complication or serious injury and death.
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Search Alerts/Recalls
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