Model Number 7211010 |
Device Problem
Pressure Problem (3012)
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Patient Problem
No Information (3190)
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Event Type
malfunction
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Event Description
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It was reported that, the "dyonics 25 control unit" had different pressure readings outside the permitted tolerance from p1 and p2 sensors.It is unknown if the event happened during surgery.Therefore, no patient involvement or surgical complications could be confirmed.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Manufacturer Narrative
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H10 h3,h6: the reported device, used in treatment, was received for evaluation.There was no relationship found between the returned device and the reported incident.A visual inspection was performed on the product and lid and bezel were scratched and dented.Complaint of incorrect pressure readings could not be confirmed.Product failed functional testing with a blank touchscreen after power up.No further functional testing could be performed.The complaint was not confirmed and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.The device has been in service for over 13 years, thus any malfunction presented at this point in time would not be related to the manufacture of the product.A complaint history review concluded this was a repeat issue.
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Manufacturer Narrative
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B5: event description updated.
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Event Description
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It was reported that, during a shoulder arthroscopy, the "dyonics 25 control unit" had different pressure readings outside the permitted tolerance from p1 and p2 sensors.The procedure was successfully completed without delay using the same device.No patient injuries or other complications were reported.
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Search Alerts/Recalls
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