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Model Number 50000000E |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/15/2022 |
Event Type
malfunction
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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 received an error 80 (non-recoverable system error) during calibration.Per follow up via phone 03aug2021, initial reporter, biomed stated that no patient involvement and during preventative maintenance the arctic sun would not cool.After spoke with tech support, it was determined that arctic sun device had a failed mixing pump and circulation pump and would need to be sent to the depot for repair.As per additional information received via ucc on 24sep2021, there was no circulation pump issue was found and just a bad mixing pump.Because of the hours and the mixing pump failure, recommended that the user sent it in for the 2k preventive maintenance service and got the rest of the components replaced at the same time.It appeared that the depot did not had any issues with it either since they only had to put a mixing test pump in it to run the disinfection.Per sample evaluation, it was reported that the isolation board , patient temperature connector, terminal soldered pins were cracked at the circuit board, but unit was operational.It stated that the grounding label was missing for power cord.
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Event Description
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It was reported that the arctic sun device received an error 80 (non-recoverable system error) during calibration.Per follow up via phone 03aug2021, initial reporter, biomed stated that no patient involvement and during preventative maintenance the arctic sun would not cool.After spoke with tech support, it was determined that arctic sun device had a failed mixing pump and circulation pump and would need to be sent to the depot for repair.As per additional information received via ucc on 24sep2021, there was no circulation pump issue was found and just a bad mixing pump.Because of the hours and the mixing pump failure, recommended that the user sent it in for the 2k preventive maintenance service and got the rest of the components replaced at the same time.It appeared that the depot did not had any issues with it either since they only had to put a mixing test pump in it to run the disinfection.Per sample evaluation, it was reported that the isolation board , patient temperature connector, terminal soldered pins were cracked at the circuit board, but unit was operational.It stated that the grounding label was missing for power cord.
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Manufacturer Narrative
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Upon further review of investigation, bd has determined that this mdr was reported in error as it was found to be a cascading failure of an event previously reported.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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