Model Number FFPH5505 |
Device Problems
Material Integrity Problem (2978); No Apparent Adverse Event (3189)
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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 device has been received.The investigation is not yet complete; however, incoming visual inspection found that the knob was missing.Additionally, loose parts were heard inside.A follow-up report will be submitted upon completion of the device evaluation.
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Event Description
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Reportedly, post repair, the customer reported a issue with the crystals.There was no report of patient involvement.No additional information is available.
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Manufacturer Narrative
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The complaint device was returned.Device evaluation identified that the ultrasound transducer electrical check failed confirming the reported event.There were three loose piezoelectric crystals were tightened.The parameter tests were performed and all passed.A definitive root cause for the loose crystals could not be determined.This type of event will continue to be monitored.Subsequent to the initial mdr, additional review of the hhe-2019-01 and hhe-2019-02 assessments have been conducted.The health care professional has concluded all fetal transducer products in relation to the resulted recall for both hhe's provided, do not qualify as reportable incidences; therefore, this malfunction should not have been submitted.
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Search Alerts/Recalls
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