Model Number 50000000 |
Device Problem
Nonstandard Device (1420)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/15/2022 |
Event Type
malfunction
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Event Description
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It was reported that the arctic sun device was being preventive maintenance and would not pass the fluid delivery line inlet pressure test.Biomed stated arctic sun device has over 2000 hours and wanted to send in.As per additional information received via follow-up on (b)(6) 2022, it was stated that per wo information there was no patient involvement at the time of reported event.The customer was sending device in for repair and coming in for the 2000 preventive maintenance service.As per sample evaluation, it was reported that the display had stains under the top layer of the screen.The touchscreen sensitivity had failed.The decontamination technician reported that the display was freezing.This was due to the touch screen desensitization.As per sample evaluation results received on (b)(6) 2022, it was stated that the failed valve seals of the fluid delivery line also contributed to the reported issue.It was noted that the replacement of one tank seal was due to lifting during repairs.It was also noted that the double bend tube to the manifold and the evaporator outlet l tube due to expansion discovered during repairs.
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
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Event Description
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It was reported that the arctic sun device was being preventive maintenance and would not pass the fluid delivery line inlet pressure test.Biomed stated arctic sun device has over 2000 hours and wanted to send in.As per additional information received via follow-up on 07feb2022, it was stated that per wo information there was no patient involvement at the time of reported event.The customer was sending device in for repair and coming in for the 2000 preventive maintenance service.As per sample evaluation, it was reported that the display had stains under the top layer of the screen.The touchscreen sensitivity had failed.The decontamination technician reported that the display was freezing.This was due to the touch screen desensitization.As per sample evaluation results received on 15jul2022, it was stated that the failed valve seals of the fluid delivery line also contributed to the reported issue.It was noted that the replacement of one tank seal was due to lifting during repairs.It was also noted that the double bend tube to the manifold and the evaporator outlet l tube due to expansion discovered during repairs.
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Manufacturer Narrative
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Upon further review, bd has determined that this mdr was reported in error.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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Search Alerts/Recalls
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