Model Number 816300 |
Device Problem
Inadequate User Interface (2958)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/10/2020 |
Event Type
malfunction
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Event Description
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It was reported that prior to use of the device for a cardiopulmonary bypass (cpb) procedure, the central control monitor (ccm) touchscreen was not responding appropriately.It was noticed that there was fluid inside the screen.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was a 10 minute delay.There was no blood loss, nor adverse consequences to the patient.Per clinical review: during set up for a cpb procedure on (b)(6) 2020, the perfusionist was making adjustments on the ccm using the touchscreen with her finger when the cursor kept trying to go back to the bottom of the screen.After a closer inspection it appeared as if fluid had gotten into the screen through a small hole and settled at the bottom of the ccm.The biomedical engineer mentioned that the hospital cleaning staff uses a lot of cleaning fluid on the equipment and that could have caused the hole or the hole could have been there prior and the fluid got in due to excessive cleaning fluid.The team opted to exchange the ccm and the ccm and cable were removed from the heart lung machine (hlm) base and a back-up was placed onto the system to use for the case.There was about a ten minute delay in the start of the procedure.The procedure then proceeded with no blood loss or harm.
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Manufacturer Narrative
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The field service representative (fsr) verified the issue.The central control monitor (ccm) touchscreen was observed as not functional.The cursor did not work even with an external mouse connected.The end user reported to the fsr that there was liquid dropped on the screen and caused the damage.As a result, a loaner ccm was installed.The unit operated to manufacturer's specifications.The suspect device was returned to the manufacturer for further evaluation.
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Manufacturer Narrative
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During laboratory analysis, the product surveillance technician (pst) observed the central control monitor (ccm) pointer gravitated towards the screen damage and was unable to be moved to select any applications.There was excessive scratching with one visible nick to the screen membrane.A lab use only (luo) touchscreen panel was installed in the ccm and it functioned as intended.It was determined that the touchscreen panel was defective, likely from the abrasive item used on the display.
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Manufacturer Narrative
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The reported complaint was confirmed.The product will be sent to service to be brought to manufacturer¿s specifications before being returned to the customer.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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