Model Number 81000 |
Device Problems
Mechanical Problem (1384); Device Slipped (1584); Insufficient Information (3190)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/03/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation: the service engineer was able to confirm the reported problem.The engineer found that the push button for the iv pole was very sensitive, causing the iv pole assembly to drop down when lightly touched or when the device was moved.The technician used a adjustable wrench and allen key to shorten the bolt on the back of the push button.Reinstalled the side panel and noted a greater distance was now needed to be pushed in order for the iv pole assembly to moved.Then performed a full system auto test with no failures recorded.Lastly conducted a visual inspection finding no other issues with the trima.One year of service history was reviewed for this device with no further issues related to the reported condition identified.Correction: a field service engineer adjusted the iv pole push button.Investigation is in process, a follow-up report will be provided.
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Event Description
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The customer reported that the iv pole on the trima equipment unexpectedly lowers down.No adverse event occurred and no medical intervention was required.Iv pole clamp was not installed.No injury was reported for this incident and no patient was connected at the time the iv pole was sliding down, therefore no patient information is reasonably known.
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Event Description
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The customer reported that the iv pole on the trima equipment unexpectedly lowers down.No adverse event occurred and no medical intervention was required.Iv pole clamp was not installed.No injury was reported for this incident and no patient was connected at the time the iv pole was sliding down, therefore no patient information is reasonably known.
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Manufacturer Narrative
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This report is being filed to provide additional information in h.6 and h.11.Investigation: the service engineer was able to confirm the reported problem.The engineer found that the push button for the iv pole was very sensitive, causing the iv pole assembly to drop down when lightly touched or when the device was moved.The technician used a adjustable wrench and allen key to shorten the bolt on the back of the push button.Reinstalled the side panel and noted a greater distance was now needed to be pushed in order for the iv pole assembly to moved.Then performed a full system auto test with no failures recorded.Lastly conducted a visual inspection finding no other issues with the trima.The device serial number history report indicates no further related issues has been reported for this device.One year of service history was reviewed for this device with no further issues related to the reported condition identified.Correction: a field service engineer adjusted the iv pole push button.Root cause: a root cause assessment was performed for this complaint.The root cause was determined to be related to the need for an adjustment of the iv pole locking bolt and screw.
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Search Alerts/Recalls
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