Model Number 18081 |
Device Problem
Temperature Problem (3022)
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Patient Problems
Unspecified Infection (1930); Sore Throat (2396)
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Event Date 07/13/2022 |
Event Type
Injury
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Event Description
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Devilbiss healthcare received a medwatch report regarding an incident involving an oxygen concentrator, which states "patient smoking with oxygen on and sustained second degree burns to face." there is no statement or evidence in the report suggesting the oxygen concentrator malfunctioned or in any way caused or contributed to the patient injury.The unit was returned to devilbiss for evaluation, and the evidence indicates the root cause of the thermal damage to the unit was the result of an external heat/fire source, which is consistent with the report of the patient smoking while using the oxygen concentrator.The unit was repaired and is operating to specification.".
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Event Description
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(b)(6) healthcare was notified of an incident involving the tubing of an end users nebulizer becoming very warm to the touch.The reporter of the incident indicated that the end user sustained a yeast infection in her throat which became blistered.The reporter of the incident indicated that it was unclear if the injury was from the medicine or a combination of the heat, which they felt was excessive.There was no information regarding an medical attention received.Multiple attempts were made to obtain additional information.Repeated attempts to obtain additional information and arrange for the device to be returned for evaluation and investigation were unsuccessful.(b)(6) healthcare believes they will be unable to gather additional information.If pertinent information becomes available at a later date, an addendum to this report will be filed.
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Manufacturer Narrative
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(b)(6) healthcare previously reported in section b5 of receiving a medwatch report regarding an incident involving an oxygen concentrator, which states "patient smoking with oxygen on and sustained second degree burns to face." there is no statement or evidence in the report suggesting the oxygen concentrator malfunctioned or in any way caused or contributed to the patient injury.The unit was returned to (b)(6) for evaluation, and the evidence indicates the root cause of the thermal damage to the unit was the result of an external heat/fire source, which is consistent with the report of the patient smoking while using the oxygen concentrator.The unit was repaired and is operating to specification." this was not the correct narrative for this submission.This issue was reported on mdr 2515872-2022-00112.The correct narrative for this issue is in section b5 of this report.
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Search Alerts/Recalls
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