Catalog Number IAP-0700 |
Device Problem
Defective Device (2588)
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Patient Problem
Insufficient Information (4580)
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Event Date 02/26/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Qn#(b)(6) n/a other remarks: n/a corrected data: n/a.
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Event Description
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It was reported that "pump lost power while on patient.Check for proper ecg and triggering.Check for proper ecg and triggering.Ran pump for 1.5 hours.No problem.Replace battery and power supply.Found blood back and system error 3.Replace blood back components and mforce driver.Check ecg skin and monitor triggering.No problems found".No patient harm or injury.The current patient status is reported as "unknown".
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Manufacturer Narrative
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(b)(4).The reported complaint of triggering difficulty is not able to be confirmed.No part or recorder strip was returned for investigation.According to the service report, the field service agent checked the pump and could not duplicate the issue.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.Other remarks: n/a.Corrected data: n/a.
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Event Description
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It was reported that "pump lost power while on patient.Check for proper ecg and triggering.Check for proper ecg and triggering.Ran pump for 1.5 hours.No problem.Replace battery and power supply.Found blood back and system error 3.Replace blood back components and mforce driver.Check ecg skin and monitor triggering.No problems found".No patient harm or injury.The current patient status is reported as "unknown".
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Search Alerts/Recalls
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