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Catalog Number 50000101 |
Device Problem
Improper or Incorrect Procedure or Method (2017)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/06/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
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Event Description
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It was reported that during the preliminary functional test, a metallic rattling noise was heard from the device.It was localized in the hgbv, the preventive maintenance.When the water was emptied, it was determined that it was very heavily contaminated, it had a brown color and dirt particles.
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Manufacturer Narrative
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The reported issue was unconfirmed.The root cause of the reported issue was unable to be determined, as the device met specifications during evaluation.The technician cannot confirm contamination in the device.The unit underwent preventive maintenance (pm) servicing as normal.Device passed all final test procedures after replacement of preventive maintenance components.The device history record review and labeling review was not required as the reported event was unconfirmed.H11: section a through f - the information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.H3 other text : the actual/suspected device was inspected.
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Event Description
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It was reported that during the preliminary functional test, a metallic rattling noise was heard from the device.It was localized in the hgbv, the preventive maintenance.When the water was emptied, it was determined that it was very heavily contaminated, it had a brown color and dirt particles.
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Search Alerts/Recalls
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