Catalog Number 0620040611 |
Device Problems
Increase in Pressure (1491); Use of Device Problem (1670)
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Patient Problems
Myocardial Infarction (1969); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/13/2023 |
Event Type
Injury
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Event Description
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It was reported that the patient suffered a heart attack.The patient is now well.
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
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Event Description
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It was reported that the patient suffered a heart attack.The patient is now well.
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Manufacturer Narrative
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This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: serious injury due to patient experiencing a heart attack.Probable root cause: 1.Pressure sensor malfunction / out of calibration.2.Software malfunction.3.Use error: 4.System design.5.Unwanted movement of internal components / wiring.6.Pressure button does not disengage.The reported failure mode will be monitored for future reoccurrence.
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Search Alerts/Recalls
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