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Model Number 50000000E |
Device Problem
Insufficient Heating (1287)
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Patient Problems
No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/27/2021 |
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 biomed needed technical support for an error 47 (control panel communication) and hence, it was transferred to technical support.Per follow up via biomed on (b)(6) 2021, replaced heating pump and circulation pump.Talked with sales rep and technical support about ordering a isolation card, control panel, and a processing card to cover the bases and the device would be repaired on site.
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Manufacturer Narrative
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Upon further review, bd has determined that this mdr was initially reported in error as this event is not reportable.H11: section a through f - the information provided by bard 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 bard.H3 other text : the device was not returned.
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Event Description
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It was reported that the biomed needed technical support for an error 47 (control panel communication) and hence, it was transferred to technical support.Per follow up via biomed on 27jan2021, replaced heating pump and circulation pump.Talked with sales rep and technical support about ordering a isolation card, control panel, and a processing card to cover the bases and the device would be repaired on site.
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Search Alerts/Recalls
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