Device Problem
Device Alarm System (1012)
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Patient Problems
Dyspnea (1816); Low Oxygen Saturation (2477)
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Event Type
malfunction
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Manufacturer Narrative
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Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Udi # is unknown.No information has been provided to date.
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Event Description
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It was reported that the patient had 4 cassettes which were affected by the medical device correction.The patient reported that she was getting "no disposable attached" alarms and for the past two days, and experienced shortness of breath and lower levels (ongoing).The patient was advised to mix a new cassette, using unaffected cassettes.The patient was advised to mix a new cassette using unaffected cassettes.
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Manufacturer Narrative
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Received patient identifiers.Initials (b)(6), date of birth (b)(6) 1956.
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Manufacturer Narrative
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A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No product was returned; therefore, the reported complaint could not be confirmed and the root cause could not be determined.If the product is returned, this complaint will be reopened for further investigation.
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Search Alerts/Recalls
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