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Model Number UDSX700S11F |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Pressure Problem (3012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/13/2022 |
Event Type
malfunction
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Event Description
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The manufacturer became aware of an allegation from a user of a dreamstation auto bipap device.The device was set in the cpap mode in error and the user went to the distributor to get the settings changed.The distributor was unable to access the bipap settings to set the machine to the correct pressures.There was no report of patient harm or injury.There was no report of medical intervention.The customer/distributor stated the device will not be returned any time soon.The user feels he/she received the wrong device.The device was replaced for the user with the correct settings.If additional information becomes available or if the device is returned for investigation, a follow up report will be filed.
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Manufacturer Narrative
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H3 other text : device not returned to the manufacturer.
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Search Alerts/Recalls
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