ARJOHUNTLEIGH POLSKA SP. Z O.O. ATMOSAIR 9000; MATTRESS, FLOTATION THERAPY, NON-POWERED
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Model Number UNKNOWN |
Device Problem
Use of Device Problem (1670)
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Patient Problem
Pressure Sores (2326)
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Event Type
Injury
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Event Description
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On (b)(6) 2023 arjo became aware of patient who developed a serious injury while laying on atmosair 9000, which is a hybrid mattress.A patient developed a deep tissue injury (dti) of the coccyx area.The same facility reported 2 additional serious injuries, which were submitted under medwatch #3007420694-2023-00029 and 3007420694-2023-00031.The investigation, which included an interview with the customer, revealed that several factors may have contributed to the pressure injuries: staff was using the bleach, which may have degraded the cover fabric, the mattress was not checked for wear, the customer's staff did not have protocols in place for moisture and continence reduction; covid changes required changes in hiring new employees who needed education.
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Manufacturer Narrative
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The product instructions for use provides guidance, information and recommendation on how to maintain the mattress, including its cleaning and regular verification for wear.The document states "check the mattress surface for tears or cracking; do not use if tears or cracks are present¿.In terms of skin care and patient monitoring, the document states: ¿remove excess moisture and keep skin dry and clean.Check patient¿s skin regularly, particular in areas where incontinence and drainage occur¿.Based on the above, it was determined that pressure injury may have developed as a result of insufficient patient skin monitoring and mattress maintenance.The product assessment, product cleaning and best practice have already been discussed with the customer.The atmosair 9000 was used for a patient treatment when the patient developed a serious injury and was therefore involved in the event.The mattress cover may have failed, however the failure was related to the lack of mattress maintenance, as recommended by the product instruction for use, not the device itself.This event is reportable solely due to indication of a serious injury development while using of the arjo product.
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