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Model Number 6300 |
Device Problem
Device Alarm System (1012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/23/2024 |
Event Type
malfunction
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Manufacturer Narrative
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H3: device not received by manufacturer.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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Event Description
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It was reported that the device's screen was blank, the device would not power on, the batteries were removed and reinserted.The device exhibited error 1840.Troubleshooting was performed but the alarm persisted.No adverse patient effects were reported by the customer.
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Manufacturer Narrative
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No product was returned.We are unable to confirm the reported complaint.If the product is returned, the manufacturer will reopen this complaint for further investigation.The root cause was unable to be established.The service history review had no indication that the complaint was related to a service of the device within the review period.
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Search Alerts/Recalls
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