Model Number 651001DAR |
Device Problem
Pressure Problem (3012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/31/2022 |
Event Type
malfunction
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Event Description
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A malfunction of the nimbus professional mattress was reported to arjo by the customer staff.Following information gathered, the mattress was allegedly 'not properly inflated'.The patient rolled against the side rails.The patient was removed from the mattress and the device was excluded from use.No fall, and neither injury was claimed.
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Manufacturer Narrative
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Analysis of the claimed malfunction is ongoing to establish root cause of the event.Additional information will be provided upon conclusion of the investigation.
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Manufacturer Narrative
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The mattress involved in the claimed to be returned to the manufacturer to be inspected at the manufacturing site.It is currently in transit.Results of the evaluation will be provided to the follow-up report.
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Manufacturer Narrative
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The mattress involved in the claimed event was returned to the manufacturer on 27 feb 2023.During the evaluation, no issue was found.It inflated correctly.The investigation is in progress, the final conclusions will be forwarded within 30 days.
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Manufacturer Narrative
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A malfunction of the nimbus professional mattress was reported to arjo by the customer staff.Following information gathered, the mattress was allegedly 'not properly inflated'.The patient rolled against the side rails.The patient was removed from the mattress and the device was excluded from use.No fall, neither injury was claimed.The involved mattress was inspected by the arjo service technician.The claimed issue was not duplicated, no over-inflation was observed.The technician detected only disconnected cpr (cardio-pulmonary resuscitation) hose but it was not responsible for the claimed issue.The cpr hose disconnection from the cpr unit will cause the mattress deflation.The pump was also inspected and no issue was found.The claimed mattress was returned to the manufacturer and it was inspected again.The mattress inflated correctly, no issues were found.It is unknown why the customer observed mattress over-inflation as during the evaluation the mattress inflated correctly.The cause of the issue was not established.In summary, the mattress allegedly inflated incorrectly and from that perspective, the nimbus professional mattress did not meet the performance specification.The arjo device played role in the event as the mattress was in use at that time.No injury, neither fall occurred.The complaint was assessed as reportable due to the allegation "the mattress was not properly inflated because the patient rolled against the siderails".
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Search Alerts/Recalls
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