Model Number BSM-6301A |
Device Problems
Device Alarm System (1012); False Alarm (1013)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/12/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 when additional information becomes available.Manufacturer's reference # (b)(4).
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Event Description
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The biomedical engineer reports that the unit alarmed vtach/vfib, but the staff states that it should have been afib.Biomed also states that this occurred from 7:24am to 8:17am, during that time they could not stop the unit from alarming.The customer also stated that this affected their phone system because it was sending them the vtach/vfib alerts for about an hour.No patient harm was reported.
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Event Description
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The biomedical engineer (bme) reported that the bedside monitor (bsm) alarmed for vtach/vfib, but the staff stated it should have been for afib.The bme also stated that this occurred from 7:24am to 8:17am, during that time they could not stop the unit from alarming and sending the alarms to their phone system.No patient harm was reported.
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Manufacturer Narrative
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Details of complaint: the biomedical engineer (bme) reported that the bedside monitor (bsm) alarmed for vtach/vfib, but the staff stated it should have been for afib.The bme also stated that this occurred from 7:24am to 8:17am, during that time they could not stop the unit from alarming and sending the alarms to their phone system.No patient harm or injury was reported.Investigation summary: as the reported device was not returned for evaluation, the reported issue could not be duplicated nor confirmed.As such, a root cause cannot be determined.The customer failed to respond to follow up attempts for additional information and troubleshooting to resolve the issue.The root cause is likely related to user education or use error based on the information made available.A serial number review of the reported device does not reveal additional related complaints.A complaint history review of the customer's account does not reveal complaint reporting of similar events.
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Search Alerts/Recalls
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