Model Number 3301 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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It was reported that the information that comes up on the screen is not correct.Patient involvement is unknown.
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Manufacturer Narrative
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Other, other text: b3: date of event and d4: udi section are unknown, no information has been provided to date.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.
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Manufacturer Narrative
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Device evaluation: no product sample was received; therefore, visual and functional testing could not be performed.The most probable cause is a faulty main board or a faulty spo2 probe/spo2 cable.The reported issue could not be confirmed.If the product is returned, the manufacturer will reopen this complaint for further investigation.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.
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Event Description
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Additional information was received: there is no patient involvement and no patient or clinical injury.The outcome was resolved.
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Search Alerts/Recalls
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