Model Number 816571 |
Device Problem
Fracture (1260)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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The fsr replaced the pump gut.The unit operated to the manufacturer's specifications.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
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Event Description
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The field service representative (fsr) reported that during a notice of field correction (nfc) of the device, the pump shaft was broken.There was no patient involvement.
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Manufacturer Narrative
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Updated block: h9.The reported complaint was confirmed.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
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Search Alerts/Recalls
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