Model Number MODEL 100 |
Device Problems
Component Falling (1105); Fitting Problem (2183)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/12/2014 |
Event Type
malfunction
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Event Description
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It was reported that during a device check by the distributor, the autopulse lifeband fell out of the autopulse platform.The distributor reported that the distance between the black tabs on the platform that hold the lifeband in place is too wide.They tried different lifebands but that did not resolve the issue.No patient involvement was reported.No further information was provided.
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Manufacturer Narrative
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The autopulse platform in complaint was returned to zoll on 12/02/2014 for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.
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Manufacturer Narrative
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Investigation results for the returned platform as follows: visual inspection was performed and the customer's reported complaint of the lifeband falling off of the platform's channel die cast assembly was confirmed.The platform was functionally tested and passed all test requirements.The platform ran for 15 minutes using a large resuscitation test fixture (lrtf) with no problems encountered.A review of the platform's archive was performed and found that there were no user advisories noted on the reported event date of (b)(6) 2014.Based on the investigation, the part identified for replacement was the channel die cast assembly.In summary, the reported complaint was confirmed during visual inspection and attributed to the platform's channel die cast assembly being wider than intended.
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Search Alerts/Recalls
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