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Catalog Number IAP-0700 |
Device Problems
Device Alarm System (1012); Gas/Air Leak (2946)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/05/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Qn# (b)(4).
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Event Description
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It was reported that the field service engineer was called in to service the pump, and during purge cycle, it was noted that the helium escaped out of the 1 psi relief valve due to fill valve #2 not opening.As a result, the cpm board was replaced.The pump ran for 18 hours without issue.The staff also noted that there was a system 7 error alarm.Although, the field service engineer could not reproduce the alarm.There was no report of patient consequence.
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Manufacturer Narrative
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(b)(4).Teleflex received the device for investigation.The reported complaint of "helium leak" is not confirmed.Although, the root cause of the complaint is undetermined the cpm board passed functional test specifications during complaint investigation.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.This will be monitored for any developing trends.No further action required at this time.,,.
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Event Description
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It was reported that the field service engineer was called in to service the pump, and during purge cycle, it was noted that the helium escaped out of the 1 psi relief valve due to fill valve #2 not opening.As a result, the cpm board was replaced.The pump ran for 18 hours without issue.The staff also noted that there was a system 7 error alarm.Although, the field service engineer could not reproduce the alarm.There was no report of patient consequence.
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Search Alerts/Recalls
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