Device Problem
Dent in Material (2526)
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Patient Problem
Tissue Breakdown (2681)
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Event Date 02/21/2024 |
Event Type
Injury
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Manufacturer Narrative
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Investigation is ongoing.Once the investigation results are available a supplemental report will be submitted.H3 other text : mattress not tagged by the customer for evaluation.
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Event Description
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Customer reported a serious pressure injury to a patient who was on velaris mattress.The report indicates that patient was admitted to facility on (b)(6) and the same day the unstageable pressure injury on the patient's sacrum was noted.Patient¿s pressure injury deteriorated on (b)(6).Patient had multiple comorbidities and braden score was 11.The facility is reporting that they mattresses have a dip and/or the sensation is that they may be too hard.These are mattresses built of foam, which responds to the patient¿s weight and patient¿s are supported on this foam.The investigation into the alleged dip in the center of the mattress is ongoing.This report is fulfilled taking a conservative approach, following the serious injury reported.
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Manufacturer Narrative
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The investigation is still ongoing towards the allegation.This patient had multiple comorbidities and passed away 12 days after was admitted to the hospital.It is unknown if the pressure injury caused or contributed to the patient's death as there is not enough information from the facility to make an assessment.
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Manufacturer Narrative
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Arjo conducted pressure mapping testing on the sampled mattress and found no higher pressure point.The gathered data from the testing and the complaints are being compiled and analysed.Once the investigation conclusion is completed, a supplemental report will be provided.
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Search Alerts/Recalls
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