Model Number 20421 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/28/2015 |
Event Type
malfunction
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Manufacturer Narrative
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The device involved in the complaint will be returned.Coopersurgical, inc.Is currently investigating the reported complaint condition.Once the investigation is completed a follow up report will be filed (b)(4).
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Event Description
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Reference medwatch mw5061596.(b)(4)."transwarmer would not activate/warm.Had to grab another that did activate to warm mattress for preemie baby.This is the 2nd time this has happened with this exact product.Staff didn't keep first transwarmer for reporting info.".
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Manufacturer Narrative
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(b)(4).Investigation: initiated manufacturer's investigation.No sample returned.Review dhr.Inspect returned samples.Inspect stock product.Analysis and findings: pristech investigation.Response received from supplier.Supplier found that review of the batch records indicated all samples met requirements.Potential cause for not achieving 102-105 f could be product was activated at a temperature below recommendation and therefore the mattress felt cooler than normal.Corrective actions: correction and/or corrective action: continue to monitor.Corrective action level 4: train personnel.None.Reason: no changes to process or procedures.Was the complaint confirmed? yes.Review and closure: capa required? recommended continuous improvement program (cip) complaint closure letter required? ncmr issued? other regulatory action needed: preventative action activity: reviewed.Trend and monitor to cip.
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Event Description
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Reference medwatch mw5061596.(b)(4)."transwarmer would not activate/warm.Had to grab another that did activate to warm mattress for preemie baby.This is the 2nd time this has happened with this exact product.Staff didn't keep first transwarmer for reporting info.".
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Search Alerts/Recalls
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